Trial intelligence / Profile preview

Pregabalin Augmentation in SRI-Refractory OCD

NCT00994786Phase 4

Key facts

Status: Completed
Start: Jan 2009
Primary completion: Jan 2019
Countries: 1
Sponsor: McMaster University
Modality: Small Molecules

Drugs: pregabalin
Conditions: obsessive compulsive disorder (OCD)

Overview

Phase 4, randomised, double-blind trial in obsessive compulsive disorder (OCD) comparing Pregabalin Augmentation with Placebo Augmentation (2 arms). Primary endpoints: Yale-Brown Obsessive Compulsive Scale at 12 weeks and Clinical Global Impression - Improvement at 12 weeks. Started Jan 2009; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Pregabalin Augmentation
Pregabalin + SRI
Placebo Augmentation
Placebo + SRI

Who it enrols

Outpatients with SRI-refractory OCD (Y-BOCS > 20) and no significant comorbidities or suicide risk.

Endpoints

Primary

Yale-Brown Obsessive Compulsive Scale12 weeks
Clinical Global Impression - Improvement12 weeks

Secondary

Montgomery Asberg Depression Rating Scale0 weeks
Sheehan Disability Scale12 weeks
Beck Depression Inventory12 weeks
Clinical Global Impression - Severity12 weeks
Saving Inventory - Revised12 weeks
Dimensional Yale-Brown-Obsessive Compulsive Scale12 weeks
Padua Inventory13 weeks

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