NCT04539951 - Pragmatic Trial of Obsessive-compulsive Disorder | Biotech Hunter

Enrollment

1,600

Participants

Timeline

Start Date

September 22, 2020

Primary Completion Date

June 30, 2027

Study Completion Date

December 31, 2028

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

Trial Locations (1)

200030

RECRUITING

Shanghai Mental Health Center, Shanghai