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...
Autores principales: | , , , , , , , , , , , |
---|---|
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 |