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1.
Z Kinder Jugendpsychiatr Psychother ; 49(4): 295-306, 2021 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-34240621

RESUMEN

Objective: This study investigates whether adolescents' adherence to psychotropic medication is associated with demographic and socioeconomic factors, and to what extent parents' assessments of their offspring's attitudes toward treatment correspond with the adolescents' self-report. Methods: This study is part of the multicenter SEMA study (Subjective Experience and Medication Adherence in Adolescents with Psychiatric Disorders). Adolescents' subjective attitudes toward medication and their adherence were assessed using the patient and parent versions of the QATT (Questionnaire on Attitudes Toward Treatment) and the MARS (Medication Adherence Rating Scale). Furthermore, we collected socioeconomic and demographic data. Results: Of the n = 75 adolescents included in the study, n = 45 (60 %) were classified as completely adherent. Patients receiving monotherapy were more often completely adherent than those receiving a combination of different medications. There was no statistically significant association between adherence and demographic or socioeconomic factors. Consensus between adolescents and their parents regarding adolescents' attitudes toward treatment ranged from slight (κ = 0.157) to fair (κ = 0.205). Conclusion: Incomplete medication adherence in adolescents with psychiatric disorders is a common phenomenon and still poorly understood. Demographic and socioeconomic factors do not seem to be relevant in this respect. However, adolescents' subjective attitudes towards medication, which parents are presumably unable to adequately assess, warrant more careful consideration in future research.


Asunto(s)
Trastornos Mentales , Adolescente , Humanos , Cumplimiento de la Medicación , Trastornos Mentales/tratamiento farmacológico , Padres , Psicotrópicos/efectos adversos , Encuestas y Cuestionarios
2.
Contemp Clin Trials Commun ; 29: 100982, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-36092975

RESUMEN

Background: Autism spectrum disorder (ASD) and obsessive-compulsive disorder (OCD) are mental disorders with a considerable overlap in terms of their defining symptoms. The glutamatergic agent memantine appears to be a promising candidate for the treatment of ASD and OCD in children and adolescents. The aim of this study was to investigate the clinical efficacy and tolerability/safety of memantine in this population. Methods: This randomized, double-blind, placebo-controlled multicenter add-on trial comprised patients aged 6 to 17; 9 years with a confirmed diagnosis of ASD and/or OCD. Participants were randomized to either memantine or placebo for 10 consecutive weeks, including an up-titration phase. Results: A total of 7 patients were included in the study. N = 4 (57.1%) participants were treated with verum (memantine) and n = 3 (42.9%) received placebo. Patients receiving memantine showed a more pronounced reduction in their CY-BOCS score, as well as greater CGI-Improvement, compared to patients receiving placebo. No serious adverse events (SAEs) were reported. Conclusions: Our findings, although based on a very small number of patients and therefore insufficient to draw clear conclusions, appear to be in line with the hypothesis that memantine is an effective, tolerable and safe agent for children and adolescents. Trial registration: EudraCT Number: 2014-003080-38, Registered 14 July 2014, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-003080-38.

3.
Trials ; 22(1): 178, 2021 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-33648579

RESUMEN

BACKGROUND: Low recruitment in clinical trials is a common and costly problem which undermines medical research. This study aimed to investigate the challenges faced in recruiting children and adolescents with obsessive-compulsive disorder and autism spectrum disorder for a randomized, double-blind, placebo-controlled clinical trial and to analyze reasons for non-participation. The trial was part of the EU FP7 project TACTICS (Translational Adolescent and Childhood Therapeutic Interventions in Compulsive Syndromes). METHODS: Demographic data on pre-screening patients were collected systematically, including documented reasons for non-participation. Findings were grouped according to content, and descriptive statistical analyses of the data were performed. RESULTS: In total, n = 173 patients were pre-screened for potential participation in the clinical trial. Of these, only five (2.9%) were eventually enrolled. The main reasons for non-inclusion were as follows: failure to meet all inclusion criteria/meeting one or more of the exclusion criteria (n = 73; 42.2%), no interest in the trial or trials in general (n = 40; 23.1%), and not wanting changes to current therapy/medication (n = 14; 8.1%). CONCLUSIONS: The findings from this study add valuable information to the existing knowledge on reasons for low clinical trial recruitment rates in pediatric psychiatric populations. Low enrollment and high exclusion rates raise the question of whether such selective study populations are representative of clinical patient cohorts. Consequently, the generalizability of the results of such trials may be limited. The present findings will be useful in the development of improved recruitment strategies and may guide future research in establishing the measurement of representativeness to ensure enhanced external validity in psychopharmacological clinical trials in pediatric populations. TRIAL REGISTRATION: EudraCT 2014-003080-38 . Registered on 14 July 2014.


Asunto(s)
Trastorno del Espectro Autista , Trastorno Obsesivo Compulsivo , Participación del Paciente , Adolescente , Niño , Ensayos Clínicos como Asunto , Método Doble Ciego , Humanos
4.
J Child Adolesc Psychopharmacol ; 28(9): 655-662, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-30148662

RESUMEN

OBJECTIVES: Medication nonadherence constitutes a major problem in adolescent psychiatry. Previous studies have identified various factors associated with nonadherent behavior. The aim of this study is to explore adolescents' health beliefs and subjective perceptions relating to psychotropic medication, and to statistically link these to reported medication adherence. METHODS: The findings presented in this study are part of the multicenter SEMA study (Subjective Experience and Medication Adherence in Adolescents with Psychiatric Disorders). Patients 12-18 years of age were included, who had been treated with a psychotropic medication for at least 2 weeks. The validated MARS (Medication Adherence Rating Scale) and the QATT (Questionnaire on Attitudes Toward Treatment) were used to measure adherence, and a qualitative semi-structured interview was conducted to examine patients' subjective experiences and perceptions. A conventional content analysis was conducted, and Fisher's exact tests were performed to analyze group differences between completely adherent and not completely adherent patients. RESULTS: A total of 64 patients were included in the study. 40.6% (n = 26) were classified as not completely adherent. Distribution patterns of answers to 7 out of 64 questions showed statistically significant group differences between completely and not completely adherent patients. Patients with lower adherence reported the following: feeling worse after taking medication; a lower sense of self-efficacy concerning the improvement of their symptoms; a less trustful physician-patient relationship; a worsened attitude toward medication after experiencing adverse events/"side effects"; less support from their relatives; and fewer individuals in their family who were fully informed about their condition. CONCLUSIONS: To our knowledge, this is the first interview-based study to investigate subjective experiences and health beliefs of adolescents with psychiatric disorders and to correlate these findings with rates of medication adherence. The study results will be useful for the development of tools and approaches to increase medication adherence, for example, psychoeducation programs and personalized treatment concepts.


Asunto(s)
Cumplimiento de la Medicación/estadística & datos numéricos , Trastornos Mentales/tratamiento farmacológico , Trastornos Mentales/psicología , Psicotrópicos/uso terapéutico , Adolescente , Niño , Femenino , Humanos , Entrevistas como Asunto , Masculino , Cumplimiento de la Medicación/psicología , Investigación Cualitativa , Encuestas y Cuestionarios
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