Pragmatic Trial of Obsessive-compulsive Disorder

NCT04539951 | Recruiting Phase 2

• 1 other identifier: CRC2018ZD03
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Pharmacotherapy; Treatment-naïve; Alternatives

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

  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 Outcomes (6)

• The Clinical Global Impression (CGI)

  from 2 weeks to 12 weeks, and 12 weeks to month 6.

• Beck Anxiety Inventory (BAI)

  from baseline to 12 weeks, and 12 weeks to month 6.

• Beck Depression Inventory(BDI)

  from baseline to 12 weeks, and 12 weeks to month 6.

• Obsessive-Compulsive Inventory-Revised(OCI-R)

  from baseline to 12 weeks, and 12 weeks to month 6.

• Treatment Emergent Symptom Scale (TESS)

  from 2 weeks to 12 weeks , and 12 weeks to month 6.

Other Outcomes (1)

• Complete Blood Count

  baseline

Study Arms (2)

serotonin treatment

ACTIVE COMPARATOR

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)

sequenced treatment alternatives

ACTIVE COMPARATOR

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); Drug: Fluvoxamine; Drug: Venlafaxine; Drug: Augment with Memantine; Drug: Augment with Aripiprazole

Interventions

Sertraline 200 milligram(mg) DRUG

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

serotonin treatment

Sertraline 300 milligram(mg) DRUG

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).

sequenced treatment alternatives

Fluvoxamine DRUG

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.

sequenced treatment alternatives

Venlafaxine DRUG

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.

sequenced treatment alternatives

Augment with Memantine DRUG

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

sequenced treatment alternatives

Augment with Aripiprazole DRUG

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

sequenced treatment alternatives

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (1)

• Wang P, Gu W, Gao J, Wang C, Fang J, Hu M, Xiang H, Li B, Liu N, Tang W, Wang X, Jia Y, Li Y, Cheng Y, Tang Z, Simpson HB, Stein DJ, Wang Z. 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.

  PMID: 35651818 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Fluvoxamine; Venlafaxine Hydrochloride; Memantine; Aripiprazole

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Amantadine; Adamantane; Bridged-Ring Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zhen Wang, PhD,MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Wang, PhD,MD

CONTACT

862134773516; wangzhen@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Psychiatrist

Model Details: In phase I all the participants will be initially treated for sertraline for 12 weeks.non-remmitters will be randomly allocated to five treatment arms for another 12 weeks in phase II.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 7, 2020
• Study Start: September 22, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)