Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder (OCD) Patients Resistant to Selective Serotonin Reuptake Inhibitor (SSRI) Therapy

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).

Timeline

Start

2013-11

Primary completion

2014-11

Completion

2014-11

Outcome

Missed primary endpoint

Stopped: “Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective.”

paper There was no significant difference in least squares (LS) mean change from baseline at week 17 in Y-BOCS total score PMID 28044255 ↗

paper [-6.9 (1.75) vs. -8.0 (1.78), respectively; LS mean difference 1.1; 95% CI -3.9, 6.2; p = 0.671]. PMID 28044255 ↗

Publications

• Rutrick D, Stein DJ, Subramanian G, Smith B, Fava M, Hasler G, Cha JH, Gasparini F, Donchev T, Ocwieja M, Johns D, Gomez-Mancilla B. Mavoglurant Augmentation in OCD Patients Resistant to Selective Serotonin Reuptake Inhibitors: A Proof-of-Concept, Randomized, Placebo-Controlled, Phase 2 Study. Adv Ther. 2017 Feb;34(2):524-541. doi: 10.1007/s12325-016-0468-5. Epub 2017 Jan 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mavoglurant	Small molecule	200 mg	Oral

Indications

No indication recorded.