Pragmatic Trial of Obsessive-compulsive Disorder (Proceed)

September 7, 2022 updated by: Zhen Wang, Shanghai Mental Health Center

A Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

1600

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
        • Principal Investigator:
          • Zhen Wang, Ph.D, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:They

  • 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: They

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: serotonin treatment
In experimental phase I, all recruited subjects provide written informed consent before any related procedures. Participants will receive sertraline, initially at 50mg/d, with a weekly 50mg/d further increase, to the maximum recommended dosage (200mg/d) or to the maximum tolerated dosage (less than 200mg/d). Patients will be on their maximum dose by week 4, so allowing an assessment of response at 12 weeks
Drug: Sertraline 200 milligram(mg)
All included participants will receive sertraline, initially at 50mg/d, with a weekly 50mg/d further increase, to the maximum recommended dosage (200mg/d) or to the maximum tolerated dosage (less than 200mg/d). Patients will be on their maximum dose by week 4, so allowing an assessment of response at 12 weeks
Active Comparator: sequenced treatment alternatives
If participants in In Experimental phase I do not achieve remission, they will be will be randomly assigned to the second-step treatment (Experimental phase II). The second-step therapy will consist of five treatment options including higher-than-usual-maximal dosage of sertraline, switching to fluvoxamine, switching to venlafaxine, augmentation with memantine, and augmentation with aripiprazole.
Drug: Sertraline 300 milligram(mg)
In experimental phase II, the patients in this group will remain on sertraline (higher dosage): where sertraline 200mg has been tolerated, dosage will be increased by 50mg fortnightly to a maximal dose of 300mg/d or to the maximum tolerable dose (less than 300mg/d).
Drug: Fluvoxamine
Fluvoxamine will be initiated at a dose of 50mg/d, increasing quickly to a maximal dose of 300mg/d or the maximum tolerated dose by week 4.
Drug: Venlafaxine
venlafaxine will be initiated at 75mg/d, increasingly weekly by 75mg/day, to a maximal dose of 300 mg/d or the maximum tolerated dose.
Drug: Augment with Memantine
Sertraline will be augmented with memantine initially at 5mg/d, and increasing by 5mg/d weekly to a maximal dose of 20mg/d (10mg twice daily) or the maximum tolerated dose
Drug: Augment with Aripiprazole
Sertraline will be augmented with aripiprazole, initially at 5mg/d, and increasing by 5mg/d weekly to a maximal dose of 20mg/d or the maximum tolerated dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Time Frame: from baseline to 12 weeks, and 12 weeks to month 6.
Y-BOCS is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), with separate subtotals for severity of obsessions and compulsions.Patients will be assessed at baseline, week 2, week 4, week 8, week 12, week 16, week 20, month 6.
from baseline to 12 weeks, and 12 weeks to month 6.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Clinical Global Impression (CGI)
Time Frame: from 2 weeks to 12 weeks, and 12 weeks to month 6.
The Clinical Global Impression (CGI; National Institute of Mental Health) is a clinician-rated scale to assess treatment response in patients with mental disorders. The scale contains three items: Severity of Illness; Global Improvement; Efficacy Index. It requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline measurement. Patients will be assessed at week 2, week 4, week 8, week 12, week 16, week 20, month 6.
from 2 weeks to 12 weeks, and 12 weeks to month 6.
Beck Anxiety Inventory (BAI)
Time Frame: from baseline to 12 weeks, and 12 weeks to month 6.
BAI is a 21-item inventory which identifies anxiety symptoms and quantifies their intensity. Patients will be assessed at baseline, week 2, week 4, week 8, week 12, week 16, week 20, month 6.
from baseline to 12 weeks, and 12 weeks to month 6.
Beck Depression Inventory(BDI)
Time Frame: from baseline to 12 weeks, and 12 weeks to month 6.
BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.Patients will be assessed at baseline, week 2, week 4, week 8, week 12, week 16, week 20, month 6.
from baseline to 12 weeks, and 12 weeks to month 6.
Obsessive-Compulsive Inventory-Revised(OCI-R)
Time Frame: from baseline to 12 weeks, and 12 weeks to month 6.
OCI-R is the measure of election for the assessment of obsessive-compulsive behaviors, given its validity and the short time that its administration requires. Patients will be assessed at baseline, week 2, week 4, week 8, week 12, week 16, week 20, month 6.
from baseline to 12 weeks, and 12 weeks to month 6.
Treatment Emergent Symptom Scale (TESS)
Time Frame: from 2 weeks to 12 weeks , and 12 weeks to month 6.
The Treatment Emergent Symptom Scale (TESS) is used to record side effects. The side effects are assessed on a five-point scale ranging from 0 ("no side effects") to 4 ("severe side effects"). Patients will be assessed at week 2, week 4, week 8, week 12, week 16, week 20, month 6.
from 2 weeks to 12 weeks , and 12 weeks to month 6.
Tolerability scale
Time Frame: from 2 weeks to 12 weeks , and 12 weeks to month 6.
The tolerability of treatment will be defined as side effect discontinuation in this study. as defined by the proportion of patients who discontinued treatment due to adverse events during the study.Patients will be assessed at week 2, week 4, week 8, week 12, week 16, week 20, month 6.
from 2 weeks to 12 weeks , and 12 weeks to month 6.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Blood Count
Time Frame: baseline
for safety considerations
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Collaborators

The First Affiliated Hospital of Nanchang University
West China Hospital
Guizhou Provincial People's Hospital
First Affiliated Hospital of Jinan University
Wuhan Mental Health Centre
The First Affiliated Hospital of Kunming Medical College
Suzhou Psychiatric Hospital
General Hospital of Ningxia Medical University
Nanjing Medical University
Seventh People's Hospital of Hangzhou
The first specialized hospital of harbin
The Second Affiliated Hospital of Xinxiang Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC2018ZD03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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