Cargando…

Characteristic and Early Discontinuation of Obsessive-Compulsive Disorder Trials Registered on ClinicalTrials.gov

Objective: This study aimed to analyze the characteristics and reasons of early discontinuation of obsessive-compulsive disorder (OCD) trials registered on ClinicalTrials.gov. Methods: OCD trials and relevant publications were searched on ClinicalTrials.gov and PubMed, respectively. The characterist...

Descripción completa

Detalles Bibliográficos
Autores principales: Luo, Shanxia, Guo, Qiong, Yang, Liu, Cheng, Yifan, Long, Youlin, Wang, Xinyi, Liu, Liqin, Yang, Zixin, Hu, Tengyue, Du, Liang, Chen, Min, Liao, Ga
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8350037/
https://www.ncbi.nlm.nih.gov/pubmed/34381385
http://dx.doi.org/10.3389/fpsyt.2021.650057
_version_ 1783735664977641472
author Luo, Shanxia
Guo, Qiong
Yang, Liu
Cheng, Yifan
Long, Youlin
Wang, Xinyi
Liu, Liqin
Yang, Zixin
Hu, Tengyue
Du, Liang
Chen, Min
Liao, Ga
author_facet Luo, Shanxia
Guo, Qiong
Yang, Liu
Cheng, Yifan
Long, Youlin
Wang, Xinyi
Liu, Liqin
Yang, Zixin
Hu, Tengyue
Du, Liang
Chen, Min
Liao, Ga
author_sort Luo, Shanxia
collection PubMed
description Objective: This study aimed to analyze the characteristics and reasons of early discontinuation of obsessive-compulsive disorder (OCD) trials registered on ClinicalTrials.gov. Methods: OCD trials and relevant publications were searched on ClinicalTrials.gov and PubMed, respectively. The characteristics and details regarding the timely publication of trials were recorded. Cox regression analysis was used to explore factors associated with the early discontinuation of OCD trials. Results: The analysis included 298 OCD therapy trials. Most investigations recruited <100 patients and were more likely to involve adults. Of all OCD studies identified, 67.8% were randomized and 61.4% were blind (single- or double-blind). Universities and hospitals were recorded as the two primary locations in the majority of trials. A total of 155 trials (52%) were completed; however, only 29% of those were published. Of the published trials, >70% were published at least 1 year after completion. Behavioral therapy trials were the most common type of major treatment-aimed OCD trials (39%), followed by drug trials (35.1%) and device/procedure trials (24.7%). The univariate Cox regression analysis indicated that drug trials [hazard ratio (HR) = 2.56, 95% confidence interval (CI): 1.21–5.43], absence of collaborators (HR = 3.87, 95% CI: 1.62–9.26), and sponsorship by industry (HR = 3.97, 95% CI: 1.49–10.53) were risk factors for early discontinuation of OCD trials. Further multivariate Cox regression showed that drug trials (HR = 3.93, 95% CI: 1.71–9.08) and absence of collaborators (HR = 5.17, 95% CI: 1.97–13.54) were independent risk factors for early trial discontinuation of OCD trials. The sensitivity analysis confirmed these results. Non-drug trials (OR = 3.32, 95% CI: 1.21–9.11), absence of collaborators (OR = 3.25, 95% CI: 1.10–9.60), and non-blinded trials (OR = 5.23, 95% CI: 1.05–26.2) were independent risk factors for unreported results in registry. Conclusion: The diagnosis and prevention of OCD are rarely investigated in trials. Underreporting and delayed reporting remain major problems. The type of intervention and participation of collaborators are associated with early discontinuation of OCD trials.
format Online
Article
Text
id pubmed-8350037
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-83500372021-08-10 Characteristic and Early Discontinuation of Obsessive-Compulsive Disorder Trials Registered on ClinicalTrials.gov Luo, Shanxia Guo, Qiong Yang, Liu Cheng, Yifan Long, Youlin Wang, Xinyi Liu, Liqin Yang, Zixin Hu, Tengyue Du, Liang Chen, Min Liao, Ga Front Psychiatry Psychiatry Objective: This study aimed to analyze the characteristics and reasons of early discontinuation of obsessive-compulsive disorder (OCD) trials registered on ClinicalTrials.gov. Methods: OCD trials and relevant publications were searched on ClinicalTrials.gov and PubMed, respectively. The characteristics and details regarding the timely publication of trials were recorded. Cox regression analysis was used to explore factors associated with the early discontinuation of OCD trials. Results: The analysis included 298 OCD therapy trials. Most investigations recruited <100 patients and were more likely to involve adults. Of all OCD studies identified, 67.8% were randomized and 61.4% were blind (single- or double-blind). Universities and hospitals were recorded as the two primary locations in the majority of trials. A total of 155 trials (52%) were completed; however, only 29% of those were published. Of the published trials, >70% were published at least 1 year after completion. Behavioral therapy trials were the most common type of major treatment-aimed OCD trials (39%), followed by drug trials (35.1%) and device/procedure trials (24.7%). The univariate Cox regression analysis indicated that drug trials [hazard ratio (HR) = 2.56, 95% confidence interval (CI): 1.21–5.43], absence of collaborators (HR = 3.87, 95% CI: 1.62–9.26), and sponsorship by industry (HR = 3.97, 95% CI: 1.49–10.53) were risk factors for early discontinuation of OCD trials. Further multivariate Cox regression showed that drug trials (HR = 3.93, 95% CI: 1.71–9.08) and absence of collaborators (HR = 5.17, 95% CI: 1.97–13.54) were independent risk factors for early trial discontinuation of OCD trials. The sensitivity analysis confirmed these results. Non-drug trials (OR = 3.32, 95% CI: 1.21–9.11), absence of collaborators (OR = 3.25, 95% CI: 1.10–9.60), and non-blinded trials (OR = 5.23, 95% CI: 1.05–26.2) were independent risk factors for unreported results in registry. Conclusion: The diagnosis and prevention of OCD are rarely investigated in trials. Underreporting and delayed reporting remain major problems. The type of intervention and participation of collaborators are associated with early discontinuation of OCD trials. Frontiers Media S.A. 2021-07-26 /pmc/articles/PMC8350037/ /pubmed/34381385 http://dx.doi.org/10.3389/fpsyt.2021.650057 Text en Copyright © 2021 Luo, Guo, Yang, Cheng, Long, Wang, Liu, Yang, Hu, Du, Chen and Liao. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Psychiatry
Luo, Shanxia
Guo, Qiong
Yang, Liu
Cheng, Yifan
Long, Youlin
Wang, Xinyi
Liu, Liqin
Yang, Zixin
Hu, Tengyue
Du, Liang
Chen, Min
Liao, Ga
Characteristic and Early Discontinuation of Obsessive-Compulsive Disorder Trials Registered on ClinicalTrials.gov
title Characteristic and Early Discontinuation of Obsessive-Compulsive Disorder Trials Registered on ClinicalTrials.gov
title_full Characteristic and Early Discontinuation of Obsessive-Compulsive Disorder Trials Registered on ClinicalTrials.gov
title_fullStr Characteristic and Early Discontinuation of Obsessive-Compulsive Disorder Trials Registered on ClinicalTrials.gov
title_full_unstemmed Characteristic and Early Discontinuation of Obsessive-Compulsive Disorder Trials Registered on ClinicalTrials.gov
title_short Characteristic and Early Discontinuation of Obsessive-Compulsive Disorder Trials Registered on ClinicalTrials.gov
title_sort characteristic and early discontinuation of obsessive-compulsive disorder trials registered on clinicaltrials.gov
topic Psychiatry
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8350037/
https://www.ncbi.nlm.nih.gov/pubmed/34381385
http://dx.doi.org/10.3389/fpsyt.2021.650057
work_keys_str_mv AT luoshanxia characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT guoqiong characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT yangliu characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT chengyifan characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT longyoulin characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT wangxinyi characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT liuliqin characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT yangzixin characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT hutengyue characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT duliang characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT chenmin characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov
AT liaoga characteristicandearlydiscontinuationofobsessivecompulsivedisordertrialsregisteredonclinicaltrialsgov