Effect of AFQ056 in OCD patients resistant to SSRI therapy
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, parallel-group proof of concept study to evaluate the effect of AFQ056 in Obsessive Compulsive Disorder (OCD) patients resistant to Selective Serotonin Reuptake Inhibitor (SSRI) therapy
IRAS ID
129383
Contact name
Jane Watson
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-005000-17
Clinicaltrials.gov Identifier
Research summary
Obsessive Compulsive Disorder (OCD) is a chronic and disabling mental disorder charecterised by distressing, recurrent thoughts, called obsessions, and repetitive unwanted behaviours performed either in a stereotyped way or according to strict rules, called compulsions. AFQ056 is a new drug which may be effective in treating people with OCD.
The purpose of this trial is to study if AFQ056 has beneficial effects on the symptoms of OCD and to assess the safety and tolerability of AFQ056 in OCD patients resistant to SSRI therapy. About 120 patients will take part in this study in around 35 centres globally. In the UK, there are 3 sites planned, with 12 patients in total. Patients will be asked to come to the study site 14 times over about 6 months. This includes a screening period of up to 6 weeks and a treatment period of 19 weeks. Patients with OCD who have not responded adequately to SSRI will be randomised to receive either AFQ056 or placebo (dummy drug). Ongoing treatment with SSRI will be allowed throughout the treatment phase of the study, which will continue for 19 weeks. During this period, patients will be regularly assessed and their physical and mental health status carefully monitored, including for emergent adverse events. At the end of the 19 week trial period they will discontinue the study drug.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0628
Date of REC Opinion
24 Jan 2014
REC opinion
Further Information Favourable Opinion