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

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

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).

Original languageEnglish
Article number822976
JournalFrontiers in Psychiatry
Volume13
DOIs
StatePublished - 16 May 2022
Externally publishedYes

Keywords

  • alternatives
  • obsessive-compulsive disorder
  • pharmacotherapy
  • remission
  • treatment-naïve

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