Abstract
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.
Highlights
Obsessive-compulsive disorder (OCD) ranks fourth among the most common mental disorders
The ClinicalTrials.gov identifiers of the included OCD trials are shown in Supplementary Table 1
In terms of the number of OCD trials, this study demonstrated an increasing trend after 2000, peaking in 2014, and followed by a decreasing trend in 2015–2018
Summary
Obsessive-compulsive disorder (OCD) ranks fourth among the most common mental disorders. It is characterized by the occurrence of obsessions, compulsions, or both (1). Compulsions are defined as repeated behaviors or mental acts that patients wish to perform in response to obsessions (2). The prevalence of OCD throughout the lifetime of an individual is 1.6% and varies significantly with age (3). OCD occurs in all ages, it is common in children and young individuals. Females with OCD mostly exhibit compulsive behaviors (e.g., washing of hands), while males tend to demonstrate obsessions of a sexual nature (1). The World Health Organization has ranked OCD as one of the most handicapping clinical conditions due to loss of income and a decrease in quality of life (QoL) (1).
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