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RecruitingPhase 2NCT04539951

Pragmatic Trial of Obsessive-compulsive Disorder

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

Sponsor

Shanghai Mental Health Center

Enrollment

1,600 participants

Start Date

Sep 22, 2020

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing different treatments — medications, therapy, or a combination — to find what works best for people with OCD (obsessive-compulsive disorder). **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with OCD as your main condition - Your OCD symptoms are moderately severe or above (score of 20+ on the Y-BOCS scale) - You have never taken medication for OCD and have not been in OCD therapy in the past month **You may NOT be eligible if...** - You have schizophrenia, psychosis, or bipolar disorder - You have a moderate or high risk of suicide - You have had serious substance use problems in the past year - You have severe depression (BDI score 29 or higher) - You have other psychiatric or medical conditions that may interfere with treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSertraline 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

DRUGSertraline 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).

DRUGFluvoxamine

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.

DRUGVenlafaxine

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.

DRUGAugment 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

DRUGAugment 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

Locations(1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

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NCT04539951

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