Pragmatic Trial of Obsessive-compulsive Disorder

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

Interventions

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

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

Sponsors & Collaborators

• The first specialized hospital of harbin

  collaborator UNKNOWN

• Guizhou Provincial People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Suzhou Psychiatric Hospital

  collaborator OTHER

• Nanjing Medical University

  collaborator OTHER

• Wuhan Mental Health Centre

  collaborator OTHER

• Seventh People's Hospital of Hangzhou

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• The Second Affiliated Hospital of Xinxiang Medical University

  collaborator UNKNOWN

• Shanghai Mental Health Center

  lead OTHER

Principal Investigators

• Zhen Wang, PhD,MD · Shanghai Mental Health Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-22

Primary Completion

2027-06-30

Completion

2028-12-31

Countries

• China

Study Locations