Protocol for a Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD (PROCEED).

Journal: Frontiers in psychiatry

Volume: 13

Issue: 

Year of Publication: 

Affiliated Institutions:  Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Department of Psychiatry, The Second Affiliated Hospital of Xinxiang Medical University, Henan, China. Mental Health Center, General Hospital of Ningxia Medical University, Ningxia, China. Psychiatry Department, The First Affiliated Hospital of Nanchang University, Jiangxi, China. Guizhou Provincial People's Hospital, Guizhou, China. Mental Health Center, West China Hospital, The Sichuan University, Sichuan, China. Department of Medical Psychology, The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China. Hangzhou Seventh People's Hospital, Mental Health Center Zhejiang University School of Medicine, Zhejiang, China. The First Psychiatric Hospital of Harbin, Heilongjiang, China. Department of Psychiatry, The First Affiliated Hospital of Jinan University, Guangzhou, China. Wuhan Mental Health Center, Hubei, China. First Affiliated Hospital of Kunming Medical University, Kunming, China. Suzhou Guangji Hospital, Jiangsu, China. Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, United States. Department of Psychiatry and South African Medical Research Council Unit on Risk & Resilience in Mental Disorders, University of Cape Town, Cape Town, South Africa.

Abstract summary 

Selective serotonin reuptake inhibitors (SSRIs) are the first-line pharmacotherapy for obsessive-compulsive disorder (OCD), but a large proportion of patients do not achieve remission after an adequate SSRI trial. To the best of our knowledge, there have been no well-powered randomized controlled trials (RCTs) of sequenced pharmacotherapy using pragmatic research designs. China provides a unique context for undertaking such a trial that will recruit the largest treatment-naïve participants and systematically compare the efficacy of different sequenced pharmacotherapy.A pragmatic research design will be adopted, with = 1,600 treatment-naïve OCD patients initially treated for sertraline for 12 weeks, and with non-remitters then randomized to 5 different augmentation or switching pharmacotherapy options for another 12 weeks. The 5 arms will include: (1) treatment with higher than usual doses of sertraline, (2) switch to fluvoxamine, (3) switch to venlafaxine, (4) augmentation with memantine, and (5) augmentation with aripiprazole.China is uniquely positioned to recruit sufficiently large sample sizes of treatment-naïve OCD patients to compare different pharmacotherapy options; data from the proposed trial promises to help inform current clinical practice guidelines by providing important information about optimal pharmacotherapy choice for those who demonstrate no response or response but no remission to first line pharmacotherapy.The trail was registered on 27 August 2020 in ClinicalTrials.gov (https://register.clinicaltrials.gov/) (NCT04539951).

Authors & Co-authors:  Wang Pei P Gu Wenjie W Gao Jian J Wang Changhong C Fang Jianqun J Hu Maorong M Xiang Hui H Li Bin B Liu Na N Tang Wenxin W Wang Xijin X Jia Yanbin Y Li Yi Y Cheng Yuqi Y Tang Zhen Z Simpson Helen Blair HB Stein Dan J DJ Wang Zhen Z

Study Outcome 

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Statistics
Citations :  Huang Y, Wang Y, Wang H, Liu Z, Yu X, Yan J, et al. . Prevalence of mental disorders in China: a cross-sectional. epidemiological study. Lancet Psychiatry. (2019) 6:211–24. 10.1016/S2215-0366(18)30511-X
Authors :  18
Identifiers
Doi : 822976
SSN : 1664-0640
Study Population
Male,Female
Mesh Terms
Other Terms
alternatives;obsessive-compulsive disorder;pharmacotherapy;remission;treatment-naïve
Study Design
Randomized Control Trial,Cross Sectional Study
Study Approach
Country of Study
Publication Country
Switzerland