Pragmatic Trial of Obsessive-compulsive Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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).

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.

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.

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

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

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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