Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 93
Filter
Add more filters

Country/Region as subject
Affiliation country
Publication year range
1.
Acta Psychiatr Scand ; 149(3): 207-218, 2024 03.
Article in English | MEDLINE | ID: mdl-38268142

ABSTRACT

INTRODUCTION: Metabolic syndrome (MetS) is a cluster of components including abdominal obesity, hyperglycemia, hypertension, and dyslipidemia. MetS is highly prevalent in individuals with bipolar disorders (BD) with an estimated global rate of 32.6%. Longitudinal data on incident MetS in BD are scarce and based on small sample size. The objectives of this study were to estimate the incidence of MetS in a large longitudinal cohort of 1521 individuals with BD and to identify clinical and biological predictors of incident MetS. METHODS: Participants were recruited from the FondaMental Advanced Center of Expertise for Bipolar Disorder (FACE-BD) cohort and followed-up for 3 years. MetS was defined according to the International Diabetes Federation criteria. Individuals without MetS at baseline but with MetS during follow-up were considered as having incident MetS. A logistic regression model was performed to estimate the adjusted odds ratio and its corresponding 95% confidence interval (CI) for an association between each factor and incident MetS during follow-up. We applied inverse probability-of-censoring weighting method to minimize selection bias due to loss during follow-up. RESULTS: Among individuals without MetS at baseline (n = 1521), 19.3% developed MetS during follow-up. Multivariable analyses showed that incident MetS during follow-up was significantly associated with male sex (OR = 2.2, 95% CI = 1.7-3.0, p < 0.0001), older age (OR = 2.14, 95% CI = 1.40-3.25, p = 0.0004), presence of a mood recurrence during follow-up (OR = 1.91, 95% CI = 1.22-3.00, p = 0.0049), prolonged exposure to second-generation antipsychotics (OR = 1.56, 95% CI = 0.99, 2.45, p = 0.0534), smoking status at baseline (OR = 1.30, 95% CI = 1.00-1.68), lifetime alcohol use disorders (OR = 1.33, 95% CI = 0.98-1.79), and baseline sleep disturbances (OR = 1.04, 95% CI = 1.00-1.08), independently of the associations observed for baseline MetS components. CONCLUSION: We observed a high incidence of MetS during a 3 years follow-up (19.3%) in individuals with BD. Identification of predictive factors should help the development of early interventions to prevent or treat early MetS.


Subject(s)
Alcoholism , Bipolar Disorder , Metabolic Syndrome , Humans , Male , Metabolic Syndrome/epidemiology , Longitudinal Studies , Bipolar Disorder/epidemiology , Risk Factors , Incidence
2.
Article in English | MEDLINE | ID: mdl-38702455

ABSTRACT

Defining homogeneous subgroups of bipolar disorder (BD) is a major goal in personalized psychiatry and research. According to the neurodevelopmental theory, age at onset may be a key variable. As potential trait markers of neurodevelopment, cognitive and functional impairment should be greater in the early form of the disease, particularly type 1 BD (BD I). The age at onset was assessed in a multicenter, observational sample of 4190 outpatients with BD. We used a battery of neuropsychological tests to assess six domains of cognition. Functioning was measured using the Functioning Assessment Short Test (FAST). We studied the potential moderation of the type of BD on the associations between the age at onset and cognitive and functioning in a subsample of 2072 euthymic participants, controlling for potential clinical and socio-demographic covariates. Multivariable analyses showed cognition to not be impaired in individuals with early (21-30 years) and very early-life (before 14 years) onset of BD. Functioning was equivalent between individuals with early and midlife-onset of BD II and NOS but better for individuals with early onset of BD I. In contrast, functioning was not worse in individuals with very early-onset BD I but worse in those with very early-onset BD II and NOS. Early-life onset BDs were not characterized by poorer cognition and functioning. Our results do not support the neurodevelopmental view that a worse cognitive prognosis characterizes early-life onset BD. This study suggests that functional remediation may be prioritized for individuals with midlife-onset BD I and very early life onset BD 2 and NOS.

3.
Compr Psychiatry ; 117: 152333, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35714412

ABSTRACT

BACKGROUND: Childhood trauma and affective disorders are known risk factors for adult suicidal behavior. Studies have shown a mediating effect of insecure attachment on the effect of childhood trauma and suicidal behavior but so far it is not clear whether this effect is related to an attachment dimension (anxiety, avoidance). AIM: The present study sought to examine the mediating effect of attachment anxiety and avoidance on suicidal behavior. METHODS: We analyzed data on childhood trauma, attachment style, depression severity, presence of prior suicide attempts and current suicide ideation from 96 patients diagnosed with an affective disorder. Two mediation analyses were conducted to assess the effect of childhood trauma on 1) prior suicide attempts and 2) current suicidal ideation through its effect on attachment. RESULTS: We found that childhood trauma had a complete mediated effect on the presence of prior suicide attempts through its effect on avoidant attachment (a1b1 = 0.0120, 95%-CI [0.0031, 0.0276]). However, only emotional abuse had a direct influence on suicidal ideation (c' = 0.0273, p < 0.01) without any indirect effect of anxious or avoidant attachment. LIMITATIONS: Variables were not assessed in a prospective way and sample size was small. CONCLUSIONS: Our findings suggest that individuals with avoidant attachment and childhood trauma are likely to present a high suicide risk. Since avoidant attachment is associated with altered perceptions and eventual rejection of social support, we recommend to screen for attachment early and to engage patients in therapeutical approaches focusing on the client-therapist alliance.

4.
Encephale ; 48(6): 624-631, 2022 Dec.
Article in French | MEDLINE | ID: mdl-36257849

ABSTRACT

INTRODUCTION: The perinatal period is associated with high risk of relapses in women with untreated bipolar disorder (BD) and can have significant consequences on foetal and child development. Valproate is an effective mood stabilizer in BD but it is also the anticonvulsant associated to the highest risks of neurodevelopmental disorders and congenital malformations. The National Agency for the Safety of Medicines and Health Products (ANSM) changed the conditions of use and prescription of valproate in France in 2015. Its prescription is now contraindicated (i.e., not to be prescribed) in women able to have children unless alternative treatments are ineffective or not tolerated. Moreover, valproate could only be prescribed if the protocol of a specific pregnancy prevention program is followed. METHODS: A panel of experts from the French Association for Biological Psychiatry and Neuropsychopharmacology (AFPBN) provided consensus-based recommendations for switching and discontinuation of valproate in women with BD. The development of these recommendations consisted of an adaptation to French clinical practice based on a European expert opinion published in 2019. The experts discussed five real-world clinical situations in light of the scientific evidence and their clinical experience (a. Stable BD patient with valproate monotherapy who is planning pregnancy, b. Stable BD patient with valproate polytherapy who is planning pregnancy, c. Unstable BD patient with frequent relapses and valproate polytherapy who is planning pregnancy, d. Stable BD patient treated with valproate and unexpected pregnancy, e. Unstable BD patient treated with valproate and unexpected pregnancy) and developed, through several rounds of exchange drafts, a French version of clinical recommendations. RESULTS: First of all, some factors need to be considered for establishing personalized practical recommendations for a safe and effective switching or discontinuation of valproate in any clinical situations: planned pregnancy or unplanned pregnancy or current pregnancy, the existence or not of a pregnancy risk minimization program and a complete treatment history. Other factors that should be considered are the predominant polarity, the severity, the stability, the comorbidities associated with BD, the beliefs toward treatments, the family situation and the preference of the patient. The modalities for switching or discontinuation of valproate in women with BD were related to the clinical situation. First-line therapeutic alternatives such as lithium, lamotrigine, quetiapine, olanzapine or aripiprazole were preferred for patients suffering from a clinically stable BD considering pregnancy or pregnant. In patients suffering from clinically unstable BD, to reach stability was considered first. A shared decision-making should be systematically implemented and the patient must be fully informed of the risks related to an in-utero exposure to valproate, and the risks of the discontinuation/switch that is considered. CONCLUSION: Although the adaptation to French practice of the recommendations from the European expert opinion highlighted some differences in the criteria taken into consideration to guide the therapeutic decision, this expert advice will guide the clinician for switching and discontinuation of valproate in BD women able to have children or pregnant.


Subject(s)
Antipsychotic Agents , Bipolar Disorder , Child , Female , Humans , Pregnancy , Bipolar Disorder/drug therapy , Valproic Acid/adverse effects , Pregnant Women , Antipsychotic Agents/adverse effects , Anticonvulsants/adverse effects , Recurrence
5.
Acta Psychiatr Scand ; 135(5): 470-478, 2017 May.
Article in English | MEDLINE | ID: mdl-28190254

ABSTRACT

OBJECTIVE: To identify risk factors for suicide attempts (SA) in individuals commencing treatment for a manic or mixed episode. METHOD: A total of 3390 manic or mixed cases with bipolar disorder (BD) type I recruited from 14 European countries were included in a prospective, 2-year observational study. Poisson regression models were used to identify individual and treatment factors associated with new SA events. Two multivariate models were built, stratified for the presence or absence of prior SA. RESULTS: A total of 302 SA were recorded prospectively; the peak incidence was 0-12 weeks after commencing treatment. In cases with a prior history of SA, risk of SA repetition was associated with younger age of first manic episode (P = 0.03), rapid cycling (P < 0.001), history of alcohol and/or substance use disorder (P < 0.001), number of psychotropic drugs prescribed (P < 0.001) and initiation of an anticonvulsant at study entry (P < 0.001). In cases with no previous SA, the first SA event was associated with rapid cycling (P = 0.02), lifetime history of alcohol use disorder (P = 0.02) and initiation of an anticonvulsant at study entry (P = 0.002). CONCLUSION: The introduction of anticonvulsants for a recent-onset manic or mixed episode may be associated with an increased risk of SA. Further BD studies must determine whether this link is causal.


Subject(s)
Anticonvulsants/adverse effects , Bipolar Disorder/drug therapy , Suicide, Attempted/statistics & numerical data , Adult , Anticonvulsants/therapeutic use , Bipolar Disorder/psychology , Female , Humans , Male , Middle Aged , Poisson Distribution , Prospective Studies , Risk Factors
6.
Acta Psychiatr Scand ; 135(5): 460-469, 2017 May.
Article in English | MEDLINE | ID: mdl-28260234

ABSTRACT

OBJECTIVE: The aim of our study was to investigate, in bipolar patients, whether affect lability was associated with suicidal ideation incidence during 2-year follow-up, and which subtype of affect lability was associated with suicidal ideation. METHOD: A total of 319 euthymic or mildly depressed bipolar outpatients recruited in the French FondaMental Advanced Centres of Expertise for Bipolar Disorder were divided into two subgroups according to the occurrence of suicidal ideation during a 2-year follow-up. Affect lability was assessed by the French version of the Affect Lability Scale. RESULTS: Bipolar patients with high affect lability were more likely to report suicidal ideation during follow-up, even after adjustment for age, study level, rapid cycling, current depression level, anxiety disorder, and lifetime history SA (OR = 2.47; 95% CI [1.15-5.30], P = 0.01). The risk of suicidal ideation increased with the level of affect lability. More specifically, the propensity to switch from neutral to elation affect, from anxious to depressive affect (or inversely), and from neutral to anger affect predicted suicidal ideation. CONCLUSION: Reducing affective lability could become a new therapeutic target of suicidal prevention in bipolar disorder.


Subject(s)
Bipolar Disorder/psychology , Suicide, Attempted/statistics & numerical data , Adult , Aged , Female , Follow-Up Studies , Humans , Incidence , Male , Middle Aged , Prospective Studies , Psychiatric Status Rating Scales , Risk Factors , Suicidal Ideation , Suicide, Attempted/psychology
7.
Encephale ; 42(6S): S30-S32, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236990

ABSTRACT

Adverse effects of psychotropic medications must be systematically assessed during a clinical trial. This systematic and mandatory evaluation, for the patient safety first, will also allow to establish for the tested molecule, an efficiency/tolerance ratio which could be compared to preexisting medications, and guide the clinician prescriptions. These side effects are closely related to the pharmacological profile of the tested molecule, in particular its monoamine binding profile. Antipsychotics are taken as an example, with a focus on classical clinical side effects related to each monoamine transmission blocking.


Subject(s)
Clinical Trials as Topic/methods , Drug-Related Side Effects and Adverse Reactions/diagnosis , Psychotropic Drugs/adverse effects , Adverse Drug Reaction Reporting Systems/standards , Biogenic Monoamines/metabolism , Clinical Trials as Topic/statistics & numerical data , Humans , Iatrogenic Disease , Medication Adherence/statistics & numerical data , Risk Assessment , Severity of Illness Index
8.
Encephale ; 42(6S): S33-S42, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236991

ABSTRACT

Proving the efficacy of a psychotropic drug is a medical, scientific and ethical need. Psychotropic drug development is now a highly complex process, which takes several years and which is very expensive. It involves multiple steps of preclinical and clinical pharmacological refinement and testing. Methodology of studies to prove curative or preventive effect of psychotropic drugs is well codified. Preclinical studies include pharmacokinetic data, toxicology and performance in various animal models of pathology. Clinical phases are centered on randomized controlled double blind trials for demonstrating efficacy and safety/tolerability. This methodology follows strict criteria to avoid bias and to prove internal and external validity of the results. All the results from randomized controlled trials or RCTs lead to different levels of evidence of Evidence-Based Medicine (EBM): gold standard is RCTs while the lowest reference is clinical case or expert opinion. However, it is possible to level criticism at these data issued from RCTs. The main matter is that studies do not reflect the healthcare reality in daily life. For these reasons, a real debate between evaluation of efficacy and effectiveness is acute. Effectiveness refers to the overall effects of psychotropic drugs in naturalistic conditions. Furthermore, analysis of costs and financial benefits are more and more important from social and economic points of view. Official agencies and health insurances look after them very carefully. This article deals with these issues and provides examples using data from the international literature. These examples are drawn from RCTs, naturalistic studies, meta-analysis, pharmaco-economic studies and concern neuroleptics, antipsychotics, antidepressants, and mood-stabilizers.


Subject(s)
Chemoprevention , Psychotropic Drugs/pharmacology , Psychotropic Drugs/therapeutic use , Randomized Controlled Trials as Topic/methods , Chemoprevention/economics , Chemoprevention/methods , Cost-Benefit Analysis , Double-Blind Method , Humans , Meta-Analysis as Topic , Psychotropic Drugs/economics , Randomized Controlled Trials as Topic/economics , Remission Induction , Treatment Outcome
9.
Encephale ; 42(6S): S43-S46, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236992

ABSTRACT

After reminding the various phases of the development of molecules, this article will state the stages of commercialisation of treatments, underlining the FDA (Food and Drug Administration) and the EMA (European Medicine Agency) requirements. Like all the other treatments available in Europe and in the United States, the long acting injectable antipsychotics (LAI) have to prove their efficacy compared to placebo and their non-inferiority compared to a treatment of reference, usually the same molecule in the oral form. These criteria of efficacy have evolved over time. If initially classical criteria of symptomatic intensity (score on scale PANSS) were considered, criteria more adequate from a clinical perspective, such as relapse, but also related to functioning, quality of life and, more recently, costs-effectiveness have appeared. This evolution is probably due to several factors: vision on mental illness, progress in patient's rights and aspirations, but also the pregnant place of health costs recently taken in the evaluation of treatments. These modifications are also based on the indications of L.A.I., i.e. stabilized patients for whom the challenge is rehabilitation care more than the control of symptoms.


Subject(s)
Antipsychotic Agents/administration & dosage , Clinical Trials as Topic/methods , Schizophrenia/drug therapy , Antipsychotic Agents/economics , Delayed-Action Preparations/administration & dosage , Delayed-Action Preparations/economics , Drug Design , Drug Discovery , Humans , Injections, Intramuscular , Treatment Outcome
10.
Encephale ; 42(6S): S7-S11, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236996

ABSTRACT

Drug development of new compounds implies to define the dosage as well as the conditions of their use (indication, treatment duration, drug interactions, warnings …). This information requires the identification of the time course response. The decisions made during the clinical phases are now based on mathematical models. These models are continuously described and improved during all phases of the drug development using data collected in healthy volunteers and patients. Their objectives are to describe the most precisely, the link between the compound characteristics (pharmacology), the patient demographics and the effects. Further, the natural history of the disease, the placebo effect and the probability of dropping out will be integrated into the model to optimize the evaluation of the compound. These technical improvements are not only statistical, in the sense that they allow a better understanding of the advantages and pitfalls of the new drug. This article presents these methods used in psychiatry and which will become the new standard of drug evaluation.


Subject(s)
Clinical Trials as Topic/methods , Models, Theoretical , Psychiatry/methods , Animals , Clinical Trials as Topic/standards , Disease Progression , Drug Discovery/methods , Drug Evaluation, Preclinical/methods , Humans , Mental Disorders/drug therapy , Mental Disorders/pathology , Placebo Effect , Psychiatry/standards , Research Design/standards
11.
Encephale ; 42(6S): S18-S25, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236987

ABSTRACT

Placebo effect remains a crucial issue in current clinical trials. Most clinical trials rely on the hypothesis of equivalent placebo response rates in both placebo and specific drug arms ("additive model"). But contrary to this dominant and rarely questioned hypothesis, several aspects may influence placebo response. A few recent meta-analyses and reviews have shown evidence for several clinical and methodological factors, which are able to modulate placebo response. In psychiatry research, placebo response has been mainly explored through antidepressant trials. In early clinical trials, drug-placebo differences were initially significant and robust. However, more recent clinical trials have not yielded similar results, and rather show narrowed antidepressant-placebo differences. Several factors may be involved in this absence of comparability: intrinsic properties of new antidepressants, changes in clinical criteria and classifications, symptomatic remission rather than global remission criteria, industrial and institutional constraints. Moreover, results from antidepressant trials (laboratory conditions) remain hardly fully transposable to clinical routine (ecological conditions).


Subject(s)
Clinical Trials as Topic/methods , Mental Disorders/drug therapy , Placebo Effect , Antidepressive Agents/therapeutic use , Clinical Trials as Topic/standards , Depressive Disorder, Major/drug therapy , Ecosystem , Humans , Placebos , Research Design/standards
12.
Encephale ; 42(6S): S51-S59, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236994

ABSTRACT

OBJECTIVES: The first objective of this article is to summarize the history of electroconvulsive therapy (ECT) in psychiatry in order to highlight the transition from clinical level of evidence based on phenomenological descriptions to controlled trial establishing causal relationship. The second objective is to apply the criteria of causation for ECT, to focus on the dose-effect relationship criteria, and thus to analyze the conditions of application of these criteria for ECT. METHODS: A literature review exploring the use of electricity, ECT and electroencephalography (EEG) in psychiatry was conducted. The publications were identified from the Pubmed and GoogleScholar electronic databases. The scientific literature search of international articles was performed in July 2016. RESULTS: In 1784, a Royal commission established in France by King Louis XVI tested Mesmer's claims concerning animal magnetism. By doing that, the commission, including such prominent scientists as the chemist Anton Lavoisier and the scientist and researcher on electricity and therapeutics Benjamin Franklin, played a central role in establishing the criteria needed to assess the level of evidence of electrical therapeutics in psychiatry. Surprisingly, it is possible to identify the classical Bradford Hill criteria of causation in the report of the commission, except the dose-effect relationship criteria. Since then, it has been conducted blinded randomized controlled trials that confirmed the effectiveness of ECT against ECT placebos for the treatment of psychiatric disorders. At present, the dose-effect relationship criteria can be analyzed through an EEG quality assessment of ECT-induced seizures. CONCLUSIONS: EEG quality assessment includes several indices: TSLOW (time to onset of seizure activity ≤5Hz, seconds), peak mid-ictal amplitude (mm), regularity (intensity or morphology of the seizure (0-6)), stereotypy (global seizure patterning, 0-3) and post-ictal suppression (0-3). A manual rating sheet is needed to score theses indices. Such manual rating with example of EEG segments recording is proposed in this article. Additional studies are needed to validate this manual, to better establish the dose-response relationship for the ECT, and thus strengthen the position of the EEG as a central element for clinical good practice for ECT.


Subject(s)
Electroconvulsive Therapy , Evidence-Based Medicine , Seizures/therapy , Animals , Electroconvulsive Therapy/adverse effects , Electroconvulsive Therapy/history , Electroconvulsive Therapy/methods , Electroencephalography , History, 18th Century , History, 19th Century , History, 20th Century , History, 21st Century , Humans , Seizures/diagnosis , Seizures/history
13.
Encephale ; 42(6S): S47-S50, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236993

ABSTRACT

As in the usual care of patients, paraclinical investigations have today only a very modest role in clinical trials in psychiatry, mainly to complete the pre-therapeutical assessments prior to inclusion of subjects or to monitor treatment tolerance. Yet, the accumulation of data in neurosciences suggests the next emergence of biomarkers, whose interest is that they are closely associated to the biological disturbances underlying psychiatric illnesses, and that they are accessible by means of technological tools such as imaging devices. These tools allow to explore the effects on brain of psychotropic medications, such as antidepressants, antipsychotics, or mood stabilizers, in relation to their therapeutic action. The obtained results allow to consider the use of such biomarkers in clinical trials in addition to more conventional approaches. In particular, they could be used as targets to measure brain response to treatment in association with clinical response, to predict a therapeutic response from the neurofunctional characteristics of patients, or to establish the safety profile of drugs on the nervous system. The use of such biomarkers in clinical trials would help to better define the explored populations and their characteristics, as well as the variables to assess, and to better measure the impact of the treatments and their potential harmful effects on the nervous system.


Subject(s)
Biomarkers, Pharmacological/analysis , Clinical Trials as Topic/methods , Monitoring, Physiologic/methods , Neurosciences/methods , Psychiatry/methods , Antidepressive Agents/pharmacokinetics , Antidepressive Agents/therapeutic use , Antipsychotic Agents/pharmacokinetics , Antipsychotic Agents/therapeutic use , Humans , Mental Disorders/diagnosis , Mental Disorders/therapy , Psychotropic Drugs/pharmacokinetics , Psychotropic Drugs/therapeutic use
14.
Encephale ; 42(6S): S60-S64, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236995

ABSTRACT

Extensive evidence demonstrates that psychotherapy can be an efficacious and effective health care service for a wide range of mental health and health conditions. Recently, an important distinction between efficacy research and effectiveness research has been made within research focused on the outcome of psychotherapy. Data from both efficacy and effectiveness studies are fundamental to a complete understanding of the potential impact of a psychotherapy and the way to carry successful psychotherapeutics interventions to routine clinical practice. Efficacy studies, using randomized controlled trials, maximize the internal validity of a study by the use of design features, such as random assignment to a psychotherapeutic intervention and control conditions, training of therapists to a specified level of competence in providing the treatment, and ensuring that all participants have the condition that the treatment was designed to address. The randomized controlled trials allowed to objectify the efficacy of the psychotherapies in multiple pathological contexts, as we will see with the example of bipolar disorders. On the other hand, effectiveness studies strive to maximize external validity (while maintaining an adequate level of internal validity) by locating the study within clinical service sites that provide ongoing health services, using clinicians who are routinely providing psychological services and patients who have been referred to the clinical settings. These studies do not allow understanding changes and psychotherapeutic processes in real practice. A solution might be found in using pragmatic case studies in a systematic manner to constitute ecologically valid samples and measure change and psychotherapeutic processes during clinically significant periods of time.


Subject(s)
Bipolar Disorder/therapy , Clinical Trials as Topic/methods , Psychotherapy/methods , Comparative Effectiveness Research , Humans , Pragmatic Clinical Trials as Topic/methods , Randomized Controlled Trials as Topic/methods , Research Design , Treatment Outcome
15.
Encephale ; 42(6S): S12-S17, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236986

ABSTRACT

An inventory on the two critical dimensions that structure the Randomized Controlled Trial in Psychiatry, namely the definition of inclusion criteria for eligible patients for testing and the choice of psychometric methods of pathology assessment and its evolution during the experiment, considers the importance of increasingly numerous and precise international recommendations. Taking into account the formal constraints of industrial, questioning the cultural differences of the methodological approach of the tests, meeting the requirements of feasibility and ever increasing security, frequent cumbersome procedure often contrasts with the modest nature of the results. A better definition to include patients in randomized trials is desirable and it asks to return to the clinic studying the expectations of patients and their response to the therapeutic situation. Excessive standardization otherwise required for ensuring the objective nature of the assessment hampers the collection of original and varied clinical features of importance in the further definitions of indications. On the way to a resumption of the single case study, we can expect from qualitative methods applied to small groups of subjects, optimization principles of patient selection for the upcoming randomized trial and greater chance to address the relevant details of clinical response to the therapeutic situation. This is what has led to the discovery of psychotropic drugs and which is involved in the various modalities of the qualitative approach. For example, and beyond the exploration of clinical drug effects, the study of the experience of psychiatric inpatient care in the Healing Garden, conducted on a small group and on the basis of the narrative analysis of their experience, notes several operating thematic dimensions: a reduction in the perception of symptoms of the disease, the impression of regaining a foothold into reality, the interest of a differently perceived doctor-patient relationship, the advantage of renewed power to act and the recognition of the importance of support from others, patients recovering somehow « vitality ¼ of touch with reality. This suggests the possibility to establish an appropriate rating scale for such a specific therapeutic situation and to provide a more accurate and efficient recruitment for a comparative objective demonstration. Moreover, this construction of meaning reinforces the therapeutic benefit of treatment in Healing Garden and offers new dimensions for research.


Subject(s)
Patient Selection , Psychiatry/methods , Psychometrics/methods , Randomized Controlled Trials as Topic/methods , Humans , Mental Disorders/diagnosis , Mental Disorders/therapy , Mental Health Services/organization & administration , Mental Health Services/standards , Practice Guidelines as Topic , Psychiatry/standards , Psychometrics/standards , Qualitative Research , Randomized Controlled Trials as Topic/standards
16.
Encephale ; 42(6S): S26-S29, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236989

ABSTRACT

To correctly interpret the results of a randomised controlled trial (RCT), practitioners have to spot bias and other potential problems present in the trial. Internal as well as external validity of the trial are linked to the presence of such bias. The internal validity is ensured by a clear definition of the objectives of the trial. The number of patients to be included in the trial is calculated on the basis of the main objective of the trial and more precisely on the basis of the primary endpoint selected to assess the efficacy of treatment. This is the best way to ensure that the statistical significance of the result may have a clinical relevance. Internal validity depends also on the process of patients selection, the methods used to ensure comparability of groups and treatments, the criteria employed to assess efficacy, and the methods for the analysis of data. External validity refers to subjects that have been excluded from the trial, limitations of RCTs, as well as the coherence and clinical relevance of the trial. Internal validity has to be fueled by external validity.


Subject(s)
Data Interpretation, Statistical , Physicians , Randomized Controlled Trials as Topic/statistics & numerical data , Bias , Humans , Internal-External Control , Physician's Role , Randomized Controlled Trials as Topic/standards , Reproducibility of Results
17.
Encephale ; 42(6S): S2-S6, 2016 Dec.
Article in French | MEDLINE | ID: mdl-28236988

ABSTRACT

Clinical trials in psychiatry allow to build the regulatory dossiers for market authorization but also to document the mechanism of action of new drugs, to build pharmacodynamics models, evaluate the treatment effects, propose prognosis, efficacy or tolerability biomarkers and altogether to assess the impact of drugs for patient, caregiver and society. However, clinical trials have shown some limitations. Number of recent dossiers failed to convince the regulators. The clinical and biological heterogeneity of psychiatric disorders, the pharmacokinetic and pharmacodynamics properties of the compounds, the lack of translatable biomarkers possibly explain these difficulties. Several breakthrough options are now available: quantitative system pharmacology analysis of drug effects variability, pharmacometry and pharmacoepidemiology, Big Data analysis, brain modelling. In addition to more classical approaches, these opportunities lead to a paradigm change for clinical trials in psychiatry.


Subject(s)
Clinical Trials as Topic , Mental Disorders/therapy , Psychiatry/methods , Psychiatry/trends , Brain/pathology , Clinical Trials as Topic/methods , Clinical Trials as Topic/organization & administration , Clinical Trials as Topic/standards , Computer Simulation , Humans , Mental Disorders/epidemiology , Pharmacoepidemiology , Pharmacogenomic Testing/methods , Pharmacogenomic Testing/trends , Research Design/standards , User-Computer Interface
18.
Acta Psychiatr Scand ; 131(2): 129-38, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25131519

ABSTRACT

OBJECTIVE: Identifying bipolar patients at high-suicide risk is a major health issue. To improve their identification, we compared dimensional and neuropsychological profile of bipolar patients with or without history of suicide attempt, taking into account suicidal severity (i.e. admission to intensive ward). METHOD: A total of 343 adult euthymic bipolar out-patients recruited in the French FondaMental Advanced Centres of Expertise for Bipolar Disorder were divided into three subgroups: 214 patients without history of suicide attempt, 88 patients with past history of non-severe suicide attempt and 41 patients with past history of severe suicide attempt. General intellectual functioning, speed of information processing, verbal learning and memory, verbal fluency and executive functioning were assessed. RESULTS: Severe suicide attempters had lower affective intensity and lability than non-severe attempters. Severe suicide attempters outperformed non-severe attempters for verbal learning and non-attempters for Stroop word reading part after adjustment for study centre, age, gender, educational level, antipsychotics use, depression score, anxious and addictive comorbidities. CONCLUSION: Neuropsychological tasks commonly used to assess bipolar patients do not seem accurate to identify suicide attempters in euthymic patients. In the future, decision-making and emotional recognition tasks should be assessed. Moreover, clinical and neuropsychological profiles should be considered together to better define suicidal risk.


Subject(s)
Bipolar Disorder/psychology , Suicide, Attempted/psychology , Adult , Bipolar Disorder/diagnosis , Cognition Disorders/diagnosis , Cognition Disorders/psychology , Female , Humans , Male , Middle Aged , Multivariate Analysis , Neuropsychological Tests , Psychiatric Status Rating Scales
19.
Encephale ; 41(2): 123-9, 2015 Apr.
Article in French | MEDLINE | ID: mdl-24094984

ABSTRACT

INTRODUCTION: Frequent visitors of psychiatric emergency wards are an important health care problem. Previous studies underlined that 2 % to 9 % of patients induce 15 % to 33 % of total clinical activity. Those patients have chronic and severe mental illness such as schizophrenia, associated with social and financial difficulties. OBJECTIVE: The aim of this study was to describe demographic and clinical characteristics of frequent visitors to a psychiatric emergency ward in a French Academic hospital over 6years in comparison to non-frequent visitors. METHODS: The study is based on a retrospective review of the psychiatric emergency wards' administrative and medical computer databases; data that included demographic, financial, clinical, and management information. During this 6-year study, the psychiatric ward recorded 16,754 care episodes for 8800 different patients. We compared frequent visitors with other visitors using univariate and multivariate analyses. Frequent visitors were defined by a number of visits greater than 2 of the mean standard deviation. RESULTS: Two percent of patients (n=192) had nine or more visits during the period. These patients caused 21 % of the total number of the visits. In the univariate analysis, the most significant reasons for referral in frequent visitors versus others (P<0.001) were: more frequent anxiety (37.6 % vs. 32.1 %), less frequent disruptive behavior (8.4 % vs. 12.9 %), depression (7.8 % vs. 17.2 %) and suicide attempt (4.5 % vs. 11.1 %). Factors associated with frequent visitors (P<0.001), after including all significant or confounding variables (multivariate analysis), were: schizophrenia and schizophrenia spectrum disorders (OR=29.5, IC: 11.4-76), DSM-IV cluster B personality disorders (OR=5.5, IC: 3.6-8.4), mental and behavioral disorders due to psychoactive substance use (OR=4.6, IC: 3.1-7), financial assistance through social government programs (OR range: 9.1-2.4, all significant) and being homeless (OR=2.7, IC: 1.8-4). Factors associated with non-frequent visitors were mood disorders (OR=0.07, IC: 0.03-0.19) and neurotic, stress-related, and somatoform disorders (OR=0.14, IC: 0.05-0.4). Sex and age were not significant in multivariate analysis. DISCUSSION: This study identifies significant demographic and clinical factors associated with frequent visits in psychiatric emergency ward in accordance with the large majority of previous studies. We found that psychotic disorders or schizophrenia were the main diagnosis of these patients. Moreover, precariousness (homeless, financial assistance) is an important demographic factor associated with recurrence. However, contrary to numerous studies, we found no effect of sex or age. Due to this important economical and clinical burden, more specific care and alternative solutions to emergency care have to be proposed to this population of patients.


Subject(s)
Emergency Services, Psychiatric/statistics & numerical data , Health Services Misuse/statistics & numerical data , Mental Disorders/epidemiology , Mental Disorders/psychology , Academic Medical Centers/statistics & numerical data , Adolescent , Adult , Aged , Child , Chronic Disease , Female , France , Ill-Housed Persons/psychology , Ill-Housed Persons/statistics & numerical data , Humans , Male , Mental Disorders/diagnosis , Mental Disorders/therapy , Middle Aged , Patient Readmission/statistics & numerical data , Personality Disorders/diagnosis , Personality Disorders/epidemiology , Personality Disorders/psychology , Personality Disorders/therapy , Psychotropic Drugs/adverse effects , Public Assistance/statistics & numerical data , Retrospective Studies , Risk Factors , Schizophrenia/diagnosis , Schizophrenia/epidemiology , Schizophrenia/therapy , Schizophrenic Psychology , Socioeconomic Factors , Substance-Related Disorders/diagnosis , Substance-Related Disorders/epidemiology , Substance-Related Disorders/psychology , Substance-Related Disorders/therapy , Utilization Review/statistics & numerical data , Young Adult
20.
Encephale ; 41(6 Suppl 1): 6S15-7, 2015 Dec.
Article in French | MEDLINE | ID: mdl-26776385

ABSTRACT

Recent investigations performing exploratory and confirmatory factor analysis have suggested that negative symptoms are multidimensional, including evidence for at least two distinct negative symptom subdomains: diminished expression and amotivation. Guidance for selection of instruments for measurement of negative symptoms is rapidly evolving. As there are continuing advances in the description of negative symptoms, new instruments are under development, and new data on the performance of instruments emerge from clinical trials. The Scale for Assessment of Negative Symptoms (SANS), the Positive and Negative Syndrome Scale (PANSS), and the Negative Symptom Assessment-16 (NSA-16) are considered to be reliable and valid measures for negative symptom trials but differ with respect to their domain coverage, use of informants, integration of global scores, administration time and comprehensiveness of their structured interviews. In response to the 2005 NIMH - MATRICS consensus statement, work groups are field testing and refining two new measures, the Clinical Assessment Interview for Negative Symptoms (CAINS) and the Brief Negative Symptom Scale (BNSS). Both address the five currently recognized domains of negative symptoms, differentiate appetitive from consummatory aspects of anhedonia and address desire for social relationships. Thus far, both have exhibited promising psychometric properties.


Subject(s)
Psychometrics , Schizophrenia/diagnosis , Schizophrenic Psychology , Humans , Psychiatric Status Rating Scales , Schizophrenia/therapy
SELECTION OF CITATIONS
SEARCH DETAIL