Pragmatic Trial of Obsessive-compulsive Disorder (Proceed)

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    Shanghai Mental Health Center
Updated on 7 October 2022
treatment regimen


This study includes a sequenced clinical trial in order to assess the efficacy of several switching or augment strategies when initial treatment is ineffective,and to provide strong evidence for clinical practice and international guidelines for Obsessive-Compulsive Disorder treatments.


Selective Serotonin Reuptake Inhibitors(SSRIs) are the first line pharmacotherapy for Obsessive-Compulsive Disorder (OCD) according to APA(American Psychological Association)guideline. Nevertheless, a large proportion (40% or more) of patients response only partially or not at all to treatment with a SSRI. On the basis of the existing sparse literature, several pharmacotherapy options for OCD patients who do not respond, or who respond but do not remit, have been outlined in current treatment guidelines. These include

  1. treatment with higher than usual doses of an SSRI, 2) switch to a different SSRI, 3) switch to a different class of medication, 4) augmentation with a dopamine blocker, and 5) augmentation with a glutamatergic agent. There is a need for additional data, particularly real-world data, on how best to choose between these options.

This proposed Randomized Controlled Trial (RCT) study is a multi-center clinical study with a total of 13 centers that specialize in OCD patients. A randomized block design will be used in this study and all eligible participants accepted into this study will undergo an initial course of pharmacotherapy (phase I), and non-remmitters will be randomly allocated to five treatment arms (phase II). In phase I all participants will be treated with sertraline for 12 weeks.In phase II,The 5 arms will comprise 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. Clinicians and patients will know which treatment arm is being employed, but raters will be kept blind to treatment group.

Condition Obsessive-Compulsive Disorder
Treatment Venlafaxine, Fluvoxamine, Sertraline 200 milligram(mg), Sertraline 300 milligram(mg), Augment with Memantine, Augment with Aripiprazole
Clinical Study IdentifierNCT04539951
SponsorShanghai Mental Health Center
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

meet DSM-5 diagnostic criteria for OCD as the primary diagnosis
are in the age range from 18 to 65 years
have a score of at least 20 on Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
have never received medication for OCD, and have not received any form of psychotherapy for OCD in the past 1 month
have provided written informed consent

Exclusion Criteria

have met the DSM-5 diagnostic criteria for Schizophrenia Spectrum and Other Psychotic Disorders, or the Bipolar and Related Disorders
have a moderate or higher risk of suicide (⩾9 on the Suicide Module in the Mini-International Neuropsychiatric Interview (MINI))
have substance use that is sufficiently severe to possibly impact negatively on treatment adherence in the past 1 year
have severe depression with Beck Depression Inventory (BDI) score of ≥29
have comorbid psychiatric or medical disorders that may impact negatively on adherence to or on the efficacy of medication (eg borderline personality disorder, CNS disorders);
are pregnant or lactating females
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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