Conditions: Patient Diagnosed With OCD and Resistant to SSRI Treatment Failed SSRI Over 12 Weeks at Appropriate Doses
Keywords: Obsessive compulsive disorder (OCD), obsessive fears, obsessions, compulsions, OCD SSRI resistant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether AFQ056 as an add on therapy to SSRIs can have beneficial effects by reducing the total score of Y-BOCS (Yale and Brown Obsessive Compulsive Scale) in OCD patients resistant to SSRI treatment (failed SSRI over 12 weeks at appropriate doses).

Detailed description:
This was a randomized, double-blind, parallel group, placebo-controlled, 12-weeks 200 mg b.i.d oral dose treatment of AFQ056 (following a 4 week up-titration period and followed by a 3 week down-titration period) or matched placebo in patients diagnosed with OCD and on background SSRI treatment for at least 12 weeks. Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective.

Arms:
arm 1: Following baseline, approximately 60 patients who are considered eligible will be randomized to AFQ056 arm and will receive the dosing regimen of 4 weeks AFQ056 b.i.d up-titration period of 50 mg,100 mg, 150 mg and 200 mg , followed by 12 weeks AFQ056 200 mg fixed dose\* and then a 3 week down-titration of 100 mg, 50 mg and 25 mg AFQ056 b.i.d)

\*patients that do not tolerate 200 mg b.i.d may be down-titrated to 150 mg b.i.d. arm 2: Following baseline, approximately 60 patients who are considered eligible will be randomized to Placebo arm and will receive the dosing regimen of 4 weeks Placebo b.i.d up-titration period of 50 mg,100 mg, 150 mg and 200 mg , followed by 12 weeks Placebo 200 mg fixed dose\* and then a 3 week down-titration of 100 mg, 50 mg and 25 mg Placebo b.i.d) \*patients that do not tolerate 200 matching placebo AFQ056 mg b.i.d may be down-titrated to 150 mg b.i.d.

Interventions: intervention 1: AFQ056 intervention 2: Placebo
Intervention descriptions: intervention 1: mGluR5 antagonist intervention 2: Matched placebo

Protocol document: