User Experiences of Ball Blankets in Adults with Depression-Related Insomnia: A Qualitative Content Analysis Study.

Insomnia is prevalent in patients suffering from depression and may itself exacerbate the disability associated with depression and impede the path to recovery. Although crucial in ensuring meaningful interactions and interventions for patients, research on patients' experiences of depression-related insomnia and its treatment is limited. The purpose of this study was therefore to investigate how adult patients with depression-related insomnia experience sleeping with a weighted Protac Ball Blanket®, focusing on how the blanket feels and works and contributes to their subjective sleep quality experience. An inductive content analysis approach was adopted. Semi-structured interviews were conducted with 13 patients. Four categories were identified: 1) Deep and dynamic touch pressure from the plastic balls induced calmness; 2) Changing sensory impressions from the rolling balls distracted attention from distressing thoughts and emotions; 3) The ball blanket improved the quality and quantity of sleep, which increased daily well-being; 4) Sleeping with the ball blanket was associated with positive as well as negative experiences depending on personal preferences for sensory stimulation. This study explains how the Protac Ball Blanket® as a potential non-pharmacological sleep-intervention improved the sleep of adult patients with depression-related insomnia. The blanket was found meaningful for coping with sleeplessness and with mental and physical unrest.

The efficacy of ball blankets on insomnia in depression in outpatient clinics: A randomised crossover multicentre trial.

Many patients with depression report insomnia symptoms that profoundly affect their health and well-being. Non-pharmacological treatments of insomnia may be preferable for some patients. In this randomised crossover trial, we investigated the efficacy of the Protac Ball Blanket® on insomnia among patients with depression. Included patients (n = 45) were diagnosed with unipolar depression, and with subjective insomnia and poor sleep quality (Pittsburgh Sleep Quality Index Score > 5). Each patient slept 2 weeks with a Protac Ball Blanket® and 2 weeks with a control duvet. Randomisation defined the order of the 2-week sleep periods. Patients served as their own control in this design. The primary outcome was changes in total night-time sleep. Secondary outcomes were sleep-onset latency, number of awakenings, wake after sleep onset, daily use of pro necessitate sedatives and hypnotics, subjective sleep quality (Pittsburgh Sleep Quality Index), insomnia severity (Insomnia Severity Index), symptoms of depression (Hamilton Depression Rating Scale, Major Depression Inventory), symptoms of anxiety (Beck Anxiety Index), and patient-reported outcomes concerning interpersonal sensitivity, neurasthenia, anxiety and depression (Self-Reported Symptom State Scale). Paired two-sided t-tests were used to compare the means of the differences of the outcomes. Protac Ball Blanket® increased total night-time sleep by 12.9 min (95% confidence interval: 1.21-24.63, p = 0.031). Among the secondary outcomes, Protac Ball Blanket® decreased Hamilton Depression Rating Scale by 2.78 (95% confidence interval: -5.44; -0.11, p = 0.042) and Insomnia Severity Index by 2.98 (95% confidence interval: -5.45; -0.50, p = 0.020). No changes were observed in sleep-onset latency, number of awakenings, wake after sleep onset, Pittsburgh Sleep Quality Index, Major Depression Inventory, Beck Anxiety Index, Self-Reported Symptom State Scale, and medication use. The results suggest that some patients may benefit from Protac Ball Blanket® as an add-on non-pharmacological treatment to improve sleep in depression.

Cognitive Behavioral Therapy for Chronic Insomnia in Outpatients with Major Depression-A Randomised Controlled Trial.

The aim of this randomised controlled assessor-blinded trial was to examine the effect of cognitive behavioural therapy for insomnia on sleep variables and depressive symptomatology in outpatients with comorbid insomnia and moderate to severe depression. Forty-seven participants were randomized to receive one weekly session in 6 weeks of cognitive behavioural therapy for insomnia or treatment as usual. The intervention was a hybrid between individual and group treatment. Sleep scheduling could be especially challenging in a group format as patients with depression may need more support to adhere to the treatment recommendations. The primary outcome measure was the Insomnia Severity Index. Secondary measures were sleep diary data, the Dysfunctional Beliefs and Attitudes about Sleep Questionnaire, the Hamilton Depression Rating Scale, and the World Health Organization Questionnaire for Quality of Life and polysomnography. Compared to treatment as usual, cognitive behavioural therapy significantly reduced the insomnia severity index (mean ISI 20.6 to 12.1, p = 0.001) and wake after sleep onset (mean 54.7 min to 19.0 min, p = 0.003) and increased sleep efficiency (mean SE 71.6 to 83.4, p = 0.006). Total sleep time and sleep onset latency were not significantly changed. The results were supported by analyses of the other rating scales and symptom dimensions. In conclusion, cognitive behavioural therapy for insomnia as add-on to treatment as usual was effective for treating insomnia and depressive symptoms in a small sample of outpatients with insomnia and major depression. ClinicalTrials.gov Identifier: NCT02678702.

Dietary supplementation with casein glycomacropeptide, leucine and tryptophan reduces plasma amino acid levels in men.

BACKGROUND: The treatment of mania in bipolar disorders needs to be more efficient, as the manic condition creates severe problems for the patient when it comes to work, finances, relationships and health. This proof-of-concept study examines to what extent casein glycomacropeptide (CGMP) may reduce the precursors of dopamine, phenylalanine and tyrosine, in plasma, and therefore be a potential new intervention to treat acute manic episodes. METHOD: The study was designed as a double-blind randomised dose-response study of CGMP (with added leucine and tryptophan) in 15 healthy men, receiving 3 different doses of CGMP with an interval of at least 14 days. RESULTS: Administration of CGMP produced a dose-dependent depletion of plasma aromatic amino acids. The total area under the curve of plasma ratios of phenylalanine-tyrosine compared to the level of leucine-isoleucine-valine--tryptophan was CGMP (20 g): 3.648 [SE:0.3281]; CGMP (40 g): 2.368 [SE:0.1858]; and CGMP (60 g)1.887 [SE:0.2591]. A comparison of the groups showed a dose-dependent statistical difference, with a one-way ANOVA summary (Dunnett) F = 11.87, p = 0.0003, CGMP 20 g versus CGMP 40 g, p = 0.0042, CGMP 20 g versus CGMP 60 g, p = 0.0002. No significant side effects were observed. CONCLUSIONS: This study demonstrate CGMP is a well-tolerated and effective mixture, and that 60 g of CGMP produced the highest depletion of plasma aromatic amino acids (phenylalanine and tyrosine). The effect seems to be highest after 3-4 h. We therefore conclude that this dose should be the one considered for future studies involving CGMP in humans.

The efficacy of ball blankets on insomnia in depression in outpatient clinics: study protocol for a randomized crossover multicentre trial.

BACKGROUND: Depression affects approx. 4% of the global population and is often accompanied by insomnia. Medications used to treat insomnia can have side effects such as development of tolerance and addiction. The Protac Ball Blanket™ (PBB) is a non-pharmacological supplement to sedatives and hypnotics, but evidence for the efficacy of PBB is needed before the treatment is implemented. The objective of this trial is to test the efficacy of PBB on insomnia caused by depression in a randomized controlled design. METHODS: This study is a multicentre, randomized crossover trial with planned inclusion of 45 patients. The randomization procedure is permuted-block randomization with varying block sizes. Patients are allocated into either a sequence "AB" or "BA" each lasting 4 weeks (28 nights). Patients randomized to the "AB" sequence receive treatment A (Protac Ball Blanket™) in the first 2 weeks and switch to treatment B (treatment as usual) in the second period, whereas patients who are randomized to the BA sequence receive treatment B in the first period and treatment A in the second period. The participants will serve as their own control in this design. The primary outcome is changes in total sleep time. Secondary outcome measures are changes in sleep onset latency, number of awakenings, wake after sleep onset, and use of sedatives and hypnotics. Furthermore, quality of sleep, insomnia severity status, and self-reported symptoms of depression, anxiety, interpersonal sensitivity, and neurasthenia will be measured. A paired, two-sided t test to compare the means of the differences in the outcomes will be performed. DISCUSSION: This clinical trial will assess the effect of PBB on depression-related insomnia. The outcomes are of high interest as the PBB is a potential non-pharmacological supplement to medical treatment of patients with insomnia due to depression. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03730974 . Registered on 5 November 2018.

Transcranial pulsed electromagnetic fields for treatment-resistant depression: A multicenter 8-week single-arm cohort study.

BACKGROUND: The efficacy of antidepressant treatment is fair, but the efficacy is considerably lower in patients failing two or more trials underscoring the need for new treatment options. Our study evaluated the augmenting antidepressant effect of 8-weeks transcranial pulsed electromagnetic field (T-PEMF) therapy in patients with treatment-resistant depression. METHODS: A multicenter 8-week single-arm cohort study conducted by the Danish University Antidepressant Group. RESULTS: In total, 58 participants (20 men and 38 women) with a moderate to severe depression as part of a depressive disorder according to ICD-10 who fulfilled criteria for treatment resistance were included, with 19 participants being nonresponders to electroconvulsive therapy during the current depressive episode. Fifty-two participants completed the study period. Scores on the Hamilton Depression Scale 17-items version (HAM-D17) decreased significantly from baseline (mean = 20.6, SD 4.0) to endpoint (mean = 12.6, SD 7.1; N = 58). At endpoint, utilizing a Last Observation Carried Forward analysis, 49 and 28% of those participants with, respectively, a nonchronic current episode (≤2 years; N = 33) and a chronic current episode (>2 years; N = 25) were responders, that is, achieved a reduction of 50% or more on the HAM-D17 scale. At endpoint, respectively, 30 and 16% obtained remission, defined as HAM-D17 ≤ 7. On the Hamilton Scale 6-item version (HAM-D6), respectively, 51 and 16% obtained remission, defined as HAM-D6 ≤ 4. CONCLUSIONS: The findings indicate a potential beneficial role of T-PEMF therapy as an augmentation treatment to ongoing pharmacotherapy in treatment-resistant depression.

Effect of antidepressant switching between nortriptyline and escitalopram after a failed first antidepressant treatment among patients with major depressive disorder.

BACKGROUND: For patients with major depressive disorder (MDD) experiencing side-effects or non-response to their first antidepressant, little is known regarding the effect of switching between a tricyclic antidepressant (TCA) and a selective serotonin reuptake inhibitor (SSRI).AimsTo compare the switch between the TCA nortriptyline and the SSRI escitalopram. METHOD: Among 811 adults with MDD treated with nortriptyline or escitalopram for up to 12 weeks, 108 individuals switched from nortriptyline to escitalopram or vice versa because of side-effects or non-response (trial registration: EudraCT No.2004-001723-38 (https://eudract.ema.europa.eu/) and ISRCTN No.03693000 (http://www.controlled-trials.com)). Patients were followed for up to 26 weeks after switching and response was measured with the Montgomery-Åsberg Depression Rating scale (MADRS). We performed adjusted mixed-effects linear regression models with full information maximum likelihood estimation reporting ß-coefficients with 95% CIs. RESULTS: Switching antidepressants resulted in a significant decrease in MADRS scores. This was present for switchers from escitalopram to nortriptyline (n = 36, ß = -0.38, 95% CI -0.51 to -0.25, P<0.001) and from nortriptyline to escitalopram (n = 72, ß = -0.34, 95% CI -0.41 to -0.26, P<0.001). Both switching options resulted in significant improvement among individuals who switched because of non-response or side-effects. The results were supported by analyses on other rating scales and symptom dimensions. CONCLUSIONS: These results suggest that switching from a TCA to an SSRI or vice versa after non-response or side-effects to the first antidepressant may be a viable approach to achieve response among patients with MDD.Declarations of interestK.J.A. holds an Alberta Centennial Addiction and Mental Health Research Chair, funded by the Government of Alberta. K.J.A. has been a member of various advisory boards, received consultancy fees and honoraria, and has received research grants from various companies including Johnson and Johnson Pharmaceuticals Research and Development and Bristol-Myers Squibb Pharmaceuticals Limited. D.S. has served on advisory boards for, and received unrestricted grants from, Lundbeck and AstraZeneca. A.F. and P.M. have received honoraria for participating in expert panels for Lundbeck and GlaxoSmithKline.

Predictors of response to combined wake and light therapy in treatment-resistant inpatients with depression.

There is growing evidence for combined chronotherapeutic interventions as adjunctive treatments for major depression. However, as the treatments can be demanding, we need to identify predictors of response. This study aimed to describe predictors of response, remission and deterioration in the short-term phase, as well as predictors of long-term response. The predictors investigated were gender, type of depression, severity of depression, treatment resistance, quetiapine use, general self-efficacy, educational level and positive diurnal variation. Follow-up data from 27 inpatients with moderate-to-severe depression participating in a chronotherapeutic intervention were analysed. As a supplement to standard treatment, they completed 3 wake therapy sessions in the first week, 30 min daily light treatment and sleep-time stabilisation in the entire 9-week study period. Patients had a significant decrease of depressive symptoms during the first 6 days measured by HAM-D6. At Day 6, 41% of the patients responded to the treatment and 19% fulfilled the criteria of remission. Deterioration by the end of wake therapy sessions was however not uncommon. In the short-term phase, mild degree of treatment resistance was associated with remission and low educational level associated with deterioration. Positive diurnal variation (mood best in the evening) was a predictor of both short-term and long-term response to combined wake and light therapy. Furthermore, patients with evening chronotypes (measured with morningness-eveningness score) were more responsive. Our results suggest that targeting the combined chronotherapeutic intervention at patients with positive diurnal variation and evening types is a viable option.

A Preclinical Study of Casein Glycomacropeptide as a Dietary Intervention for Acute Mania.

Background: Casein glycomacropeptide is a peptide that lacks phenylalanine, tyrosine, and tryptophan. This profile may enable it to deplete phenylalanine, tyrosine, and tryptophan, and subsequently the synthesis of dopamine and serotonin in the brain. Dopamine- and serotonin-depleting amino acid mixtures have shown promise as acute antimanic treatments. In this study, we explore the depleting effects on amino acids, dopamine and serotonin as well as its actions on manic-like and other behavior in rats. Methods: Casein glycomacropeptide and a selection of amino acid mixtures were administered orally at 2, 4, or 8 h or for 1 week chronically. Amino acid and monoamine levels were measured in plasma and brain and behavior was assessed in the amphetamine-hyperlocomotion, forced swim, prepulse inhibition, and elevated plus maze tests. Results: Casein glycomacropeptide induced a time-dependent reduction in tyrosine, tryptophan, and phenylalanine in brain and plasma which was augmented by supplementing with leucine. Casein glycomacropeptide +leucine reduced dopamine in the frontal cortex and serotonin in the hippocampus, frontal cortex, and striatum after 2 and 4 h. Casein glycomacropeptide+leucine also had antimanic activity in the amphetamine-induced hyperlocomotion test at 2 h after a single acute treatment and after 1 week of chronic treatment. Conclusions: Casein glycomacropeptide-based treatments and a branched-chain amino acid mixture affected total tissue levels of dopamine in the frontal cortex and striatum and serotonin in the frontal cortex, striatum, and hippocampus of rats in a time-dependent fashion and displayed antimanic efficacy in a behavioral assay of mania.

Mechanical restraint and characteristics of patient, staff and shifts in a psychiatric ward.

BACKGROUND: The use of coercion is a balance between depriving the patients' autonomy and dignity and preventing endangerment of the body or health of self or others. It is of importance to obtain more knowledge about mechanisms leading to mechanical restraint in the attempt of reducing it. OBJECTIVE: To analyse for associations between incidence of mechanical restraint (MR) and staffing level, staff demographics, patient characteristics, type of shift (day/evening/night) and change of shifts. METHOD: A naturalistic descriptive method was used to study cases of MR in a psychiatric ward. Data for each case of MR was obtained from an electronic reporting system. Care workers from each shift were identified using duty rosters. Analyses included binary logistic regression analyses. RESULTS: In 82% of the 114 cases of MR, the patient was diagnosed with personality disorders. In the multiple regression analysis, a significant association was found between the use of MR and the presence of male care workers on the ward (OR:1.44, 95% CI: 1.01-2.05; p = .04). Moreover, MR was associated with evening shifts, compared with day and night shifts (OR =1,29, 95% CI: 1.14-2.57, p = .01). Besides, months from January to December was associated with a decrease in MRs (OR: 0.88, 95% CI: 0.83-0.94; p = 7.3 E-6). No significant associations were found between MR and staffing level or experience. CONCLUSIONS: MR was associated with evening shifts, higher number of male care workers on duty and a decrease from January to December.

Use of antidepressants in patients with depression and comorbid diabetes mellitus: a systematic review.

OBJECTIVE: Depression may be difficult to treat and with comorbid diabetes mellitus (DM) it is an even bigger challenge. This article aims to evaluate antidepressants most suitable for patients with depression and comorbid DM. Design and methods Initially we searched for randomised, controlled double-blind trials of treatment with antidepressants in depressed with DM but there were only a few studies and many of them were small trials. Thus, we decided to include studies that were not only randomised-controlled trials. In total, we ended up with 18 articles for our purposes. RESULTS: The combination of depression and DM may be harmful as depression has a strong impact on psychosocial and medical outcomes in patients with DM. Almost all of the trials in this review showed a reduction in depressive symptoms after treatment with an antidepressant in the acute as well as during maintenance phase. It showed that depression improvement had a favourable effect on glycaemic control that was weight independent. Some studies included only subjects with minor depression or with suboptimal-controlled diabetes making it difficult to show an effect. CONCLUSION: From these data, we will recommend choosing an selective serotonin reuptake inhibitor (SSRI) if possible to treat a depression among patients with diabetes. If treatment with a tricyclic antidepressant is needed, closer glycaemic monitoring is recommended. Bear in mind that there is a possible risk of hypoglycemia when using SSRIs. Agomelatine and bupropion have shown promising results, but need to be investigated in more trials.

Pregnancy and bipolar disorder: the risk of recurrence when discontinuing treatment with mood stabilisers: a systematic review.

OBJECTIVE: Bipolar disorder in pregnancy may be difficult to treat. The dilemma is whether the women should continue medication throughout pregnancy, and maybe accept a minor risk to harm their unborn child, or discontinue medication and increase the risk of recurrence, which can lead to maternal morbidity, thereby endangering themselves and their foetus. Design and methods In September 2016, three electronic search databases; PubMed, Scopus and PsycInfo, were used searching for clinical trials concerning this question. Eight clinical trials concerning risk of recurrence after discontinuation of medication in pregnancy were included. RESULTS: There is no consensus concerning the risk of discontinuation of medication during pregnancy among bipolar women. The evidence from the trials included underscore that there seem to be a group of pregnant women who are stable despite they are not receiving mood stabilisers during pregnancy. Besides, there is a group of more severe and more unstable bipolar disorders that seem to benefit of a more close monitoring, support and prophylactic medication during pregnancy and postpartum period to prevent recurrence. CONCLUSION: For the more stable bipolar women we recommend a well planned and more slowly discontinuation of medication before pregnancy. For the unplanned pregnancies it is important to consider the possibility of a more slowly discontinuation. For the more severe conditions of bipolar disorder, it is important to secure a close monitoring of medication. As the risk of postpartum relapse is high, medication may be started soon after delivery.

Experiences of wake and light therapy in patients with depression: A qualitative study.

Wake therapy can reduce depressive symptoms within days, and response rates are high. To sustain the effect, it is often combined with light therapy. Few studies have focussed on factors related to patients' adherence to the regime, and none has used qualitative methods to examine their experience of these combined interventions. Therefore, the aim of the present study was to illuminate patients' experiences with wake and light therapy and factors related to adherence. Thirteen inpatients with depression were included. They participated in an intervention consisting of three wake therapies during the first week, 30 min of daily light treatment for the entire 9 weeks, and ongoing psychoeducation regarding good sleep hygiene. Patients kept a diary, and individual semistructured interviews were conducted. Data were analysed using qualitative content analysis. The participants' overall experience with the treatment was positive. Some experienced a remarkable and rapid antidepressant effect, whereas others described more long-term benefits (e.g. improved sleep and diurnal rhythm). Yet recovery was fragile, and patients were only cautiously optimistic. Social support was important for maintaining the motivation to stay awake and receive daily light therapy. Overall, participants found the treatment worthwhile and would recommend it to others with depression. The study revealed a lack of knowledge among participants about the connection between regular sleep patterns and depression. In conclusion, this study provides insight into patients' experiences, and knowledge that can contribute to guidelines for future adherence-promoting organization of wake and light therapy.

Online information seeking by patients with bipolar disorder: results from an international multisite survey.

BACKGROUND: Information seeking is an important coping mechanism for dealing with chronic illness. Despite a growing number of mental health websites, there is little understanding of how patients with bipolar disorder use the Internet to seek information. METHODS: A 39 question, paper-based, anonymous survey, translated into 12 languages, was completed by 1222 patients in 17 countries as a convenience sample between March 2014 and January 2016. All patients had a diagnosis of bipolar disorder from a psychiatrist. Data were analyzed using descriptive statistics and generalized estimating equations to account for correlated data. RESULTS: 976 (81 % of 1212 valid responses) of the patients used the Internet, and of these 750 (77 %) looked for information on bipolar disorder. When looking online for information, 89 % used a computer rather than a smartphone, and 79 % started with a general search engine. The primary reasons for searching were drug side effects (51 %), to learn anonymously (43 %), and for help coping (39 %). About 1/3 rated their search skills as expert, and 2/3 as basic or intermediate. 59 % preferred a website on mental illness and 33 % preferred Wikipedia. Only 20 % read or participated in online support groups. Most patients (62 %) searched a couple times a year. Online information seeking helped about 2/3 to cope (41 % of the entire sample). About 2/3 did not discuss Internet findings with their doctor. CONCLUSION: Online information seeking helps many patients to cope although alternative information sources remain important. Most patients do not discuss Internet findings with their doctor, and concern remains about the quality of online information especially related to prescription drugs. Patients may not rate search skills accurately, and may not understand limitations of online privacy. More patient education about online information searching is needed and physicians should recommend a few high quality websites.

A 2-year follow-up study of patients participating in our transcranial pulsating electromagnetic fields augmentation in treatment-resistant depression.

OBJECTIVE: We have made a 2-year follow-up study to evaluate the effect of repeated transcranial pulsating electromagnetic fields (T-PEMF) augmentation in patients who had achieved remission but later on relapsed, as well as to identify factors contributing to treatment-resistant depression in patients who did not respond to T-PEMF. METHODS: Using the Longitudinal Expert Assessment of All Data approach the patients were classified in four groups: A: patients who achieved remission; B: patients with doubtful effect; C: patients with no effect; and D: patients who were hard-to-assess. RESULTS: In group A, comprising 27 patients, 13 had relapsed; they obtained a clear remission after a repeated course of T-PEMF augmentation. In group D, comprising 16 patients, we identified misdiagnostic factors both concerning the event of remission after the previous T-PEMF augmentation and concerning the aetiology (psychosocial stressors and co-morbid conditions). Compared with the other groups, the group D patients had a smaller number of previous episodes (p=0.09) and a longer duration of the current episode (p=0.01). CONCLUSION: T-PEMF has an effect among patients who relapsed after remission with the first series of T-PEMF. Treatment-resistant depression is a condition that has a high degree of multivariate problems. Misuse of alcohol or drugs, severe somatic disorders and other psychosocial problems may need other kinds of treatment before T-PEMF augmentation.

The Diagnostic Apathia Scale predicts a dose-remission relationship of T-PEMF in treatment-resistant depression.

OBJECTIVE: The aim of this study was to evaluate the predictive validity of the apathy subsyndrome in patients with therapy-resistant depression in the dose-remission study with transcranial pulsating electromagnetic fields (T-PEMF). METHODS: The apathy subsyndrome consists of the symptoms of fatigue, concentration and memory problems, lack of interests, difficulties in making decisions, and sleep problems. We evaluated 65 patients with therapy-resistant depression. In total, 34 of these patients received placebo T-PEMF in the afternoon and active T-PEMF in the morning, that is, one daily dose. The remaining 31 patients received active T-PEMF twice daily. Duration of treatment was 8 weeks in both groups. The Hamilton Depression Scale (HAM-D17) and the Bech-Rafaelsen Melancholia Scale (MES) were used to measure remission. We also focused on the Diagnostic Apathia Scale, which is based on a mixture of items from the MINI and the HAM-D17/MES. RESULTS: In patients without apathy, the remission rate after T-PEMF was 83.9% versus 58.8% in patients with apathy (p≤0.05). In patients without apathy receiving one active dose daily 94.4% remitted versus 50% for patients with apathy (p≤0.05). In patients without apathy who received two active doses 69.9% remitted versus 66.7% for patients with apathy (p≤0.05). CONCLUSION: Taking the baseline diagnosis of the apathy syndrome into consideration, we found that in patients without apathy one daily dose of T-PEMF is sufficient, but in patients with apathy two daily doses are necessary. Including the apathy syndrome as predictor in future studies would seem to be clinically relevant.

Dose-remission of pulsating electromagnetic fields as augmentation in therapy-resistant depression: a randomized, double-blind controlled study.

OBJECTIVE: To evaluate to what extent a twice daily dose of Transcranial Pulsating ElectroMagnetic Fields (T-PEMF) was superior to once daily in patients with treatment-resistant depression as to obtaining symptom remission after 8 weeks of augmentation therapy. METHODS: A self-treatment set-up of the T-PEMF device was used allowing self-administration by patients in own homes. All patients were treated for 30 min per T-PEMF session. The antidepressant medication the patients were receiving at baseline remained unchanged during the trial. The patients were randomised to either one T-PEMF dose (active dose in the morning and sham in the afternoon) or two T-PEMF doses (active dose both morning and afternoon) in a double-blind procedure. A score of 7 or less on the Hamilton Depression Scale (HAM-D17) was the criterion of remission. RESULTS: In total 34 patients received active T-PEMF once a day and 31 patients twice daily. After 5 weeks of therapy remission was obtained in 26.5% and 32.3% on one dose and two doses of T-PEMF, respectively. After 8 weeks the rate of remission was 73.5% and 67.7%, respectively. The side effects as measured by the Udvalget for Kliniske Undersøgelser scale showed a better toleration of the antidepresssive medication in both treatment groups, which was reflected by the WHO-5 well-being scale with increased scores in both groups of patients. CONCLUSION: The high remission rate obtained by the T-PEMF augmentation was not a dose effect (one versus two daily T-PEMF sessions) but was explained by the extension of the treatment period from 5 to 8 weeks.

The Hamilton Depression Scale (HAM-D) and the Montgomery-Åsberg Depression Scale (MADRS). A psychometric re-analysis of the European genome-based therapeutic drugs for depression study using Rasch analysis.

The objective of this re-analysis of the European Genome-Based Therapeutic Drugs for Depression Study (GENDEP) was to psychometrically test the unidimensionality of the full Montgomery Åsberg Depression Rating Scale (MADRS10) and the Hamilton Depression Scale (HAM-D17) versus their respective subscales (MADRS5 and HAM-D6) containing the core symptoms of depression severity. Rasch analysis was applied using RUMM 2030 software to assess the overall fit for unidimensionality. Neither the MADRS10 nor the HAM-D17 was found to fit the Rasch model for unidimensionality. The HAM-D6 (containing the items of depressed mood, guilt, work and interests, psychomotor retardation, psychic anxiety, and somatic general) as well as the analogue MADRS5 were tested for unidimensionality by use of the RUMM 2030 programme, and only the HAM-D6 was accepted. When testing for invariance across rating weeks or centres, the RUMM 2030 had to be supplemented with the Friedman two-way analysis of variance by ranks. The HAM-D6 but not the MADRS5 was accepted. It was therefore concluded that the HAM-D6 is a psychometrically valid outcome scale to measure change in clinical trials of antidepressants.

Higher-order social cognition in first-episode major depression.

Patients suffering from major depression experience difficulties in multiple cognitive faculties. A growing body of research has linked affective disorders to abnormalities in social cognition and specifically the processing of discrete emotional stimuli. However, little inquiry has gone into possible impairment in higher-order social cognition including theory of mind, social perception and metacognition. Forty-four medication-naïve patients with first-episode unipolar major depressive disorder and an equal number of matched controls were assessed by the Metacognitive Assessment Scale-Abbreviated (MAS-A), The Frith-Happé animations (FHA) and The Awareness of Social Inference Test (TASIT). Additionally, neurocognition was assessed utilyzing the Cambridge Neuropsychological Test Automated Battery (CANTAB). Depressed patients showed impairment in all domains of higher-order social cognitive ability. Importantly, social cognitive variables retained their inter-group significance after controlling for possible covariates including neurocognition. Results indicate that first-episode depressed patients experience difficulties in all domains of higher-order social cognition including theory of mind, social perception and metacognition.