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

Pei Wang; Wenjie Gu; Jian Gao; Changhong Wang; Jianqun Fang; Maorong Hu; Hui Xiang; Bin Li; Na Liu; Wenxin Tang; Xijin Wang; Yanbin Jia; Yi Li; Yuqi Cheng; Zhen Tang; Helen Blair Simpson; Dan J Stein; Zhen Wang

doi:10.3389/fpsyt.2022.822976

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

Front Psychiatry. 2022 May 16:13:822976. doi: 10.3389/fpsyt.2022.822976. eCollection 2022.

Authors

Pei Wang¹, Wenjie Gu¹, Jian Gao¹, Changhong Wang², Jianqun Fang³, Maorong Hu⁴, Hui Xiang⁵, Bin Li⁶, Na Liu⁷, Wenxin Tang⁸, Xijin Wang⁹, Yanbin Jia¹⁰, Yi Li¹¹, Yuqi Cheng¹², Zhen Tang¹³, Helen Blair Simpson¹⁴, Dan J Stein¹⁵, Zhen Wang^{1

16}

Affiliations

¹ Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
² Department of Psychiatry, The Second Affiliated Hospital of Xinxiang Medical University, Henan, China.
³ Mental Health Center, General Hospital of Ningxia Medical University, Ningxia, China.
⁴ Psychiatry Department, The First Affiliated Hospital of Nanchang University, Jiangxi, China.
⁵ Guizhou Provincial People's Hospital, Guizhou, China.
⁶ Mental Health Center, West China Hospital, The Sichuan University, Sichuan, China.
⁷ Department of Medical Psychology, The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, China.
⁸ Hangzhou Seventh People's Hospital, Mental Health Center Zhejiang University School of Medicine, Zhejiang, China.
⁹ The First Psychiatric Hospital of Harbin, Heilongjiang, China.
¹⁰ Department of Psychiatry, The First Affiliated Hospital of Jinan University, Guangzhou, China.
¹¹ Wuhan Mental Health Center, Hubei, China.
¹² First Affiliated Hospital of Kunming Medical University, Kunming, China.
¹³ Suzhou Guangji Hospital, Jiangsu, China.
¹⁴ Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, United States.
¹⁵ Department of Psychiatry and South African Medical Research Council Unit on Risk & Resilience in Mental Disorders, University of Cape Town, Cape Town, South Africa.
¹⁶ Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China.

Abstract

Background: 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.

Methods: A pragmatic research design will be adopted, with n = 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.

Discussion: 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.

Trial registration: The trail was registered on 27 August 2020 in ClinicalTrials.gov (https://register.clinicaltrials.gov/) (NCT04539951).

Keywords: alternatives; obsessive-compulsive disorder; pharmacotherapy; remission; treatment-naïve.

Associated data

ClinicalTrials.gov/NCT04539951