A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Registration Number
- NCT01674361
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin 30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their background therapy with an SSRI. Participants will be allocated to one of two strata. Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2 visit. Participants in both strata will receive the study drug in addition to their background therapy with an SSRI until Week 16.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- On a stable dose of SSRI for at least 8 weeks prior to screening an between screening and Day 1
- An insufficient response to current treatment with an SSRI given at an adequate dose for at least 12 weeks prior to Day 1
- Females who are not postmenopausal or surgically sterile and who have (or may have) male sexual partners must agree to use two adequate methods of contraception as defined by protocol from the start of screening until 90 days after the last dose of study drug
- Primary OCD symptom of hoarding
- More than two unsatisfactory trials within the last 2 years with different serotonin reuptake inhibitors (not including the current treatment with an SSRI) given in an adequate dose for at least 12 weeks
- Failure of more than three augmentation therapies within the last 2 years
- Undergoing acute behavioral therapy or having acute behavioral therapy that was completed less than 4 weeks prior to Day 1
- Any primary DSM-IV-TR Axis I disorder other than OCD
- Current or prior history of bipolar disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, or Gilles de la Tourette syndrome if symptoms have persisted into adulthood
- Any eating disorder within the last 6 months
- History of DSM-IV-TR-defined substance dependence and/or substance abuse in the last 6 months, with the exception of nicotine
- Previous treatment with bitopertin or another Glycine transporter 1 inhibitor
- Positive urine drug screening for cannabis, amphetamines (including 3,4-methylenedioxymethamphetamine [MDMA]/ecstasy), cocaine, barbiturate, and/or opiates
- Prior or current general medical condition that may impair cognition or other neuropsychiatric functioning
- Body mass index less than (<) 18.5 kilogram per square meter (kg/m^2) or greater than (>) 40 kg/m^2
- Pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bitopertin 30 mg Placebo Participants in Stratum 1 will receive bitopertin 30 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 30 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. Bitopertin 30 mg SSRI Participants in Stratum 1 will receive bitopertin 30 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 30 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. Bitopertin 10 mg Placebo Participants in Stratum 1 will receive bitopertin 10 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 10 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. Bitopertin 10 mg SSRI Participants in Stratum 1 will receive bitopertin 10 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 10 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. Placebo Placebo Participants (both Stratum 1 and Stratum 2) will receive placebo from Day 1 to Week 16 in addition to their background therapy with an SSRI. Placebo SSRI Participants (both Stratum 1 and Stratum 2) will receive placebo from Day 1 to Week 16 in addition to their background therapy with an SSRI. Bitopertin 30 mg Bitopertin Participants in Stratum 1 will receive bitopertin 30 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 30 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. Bitopertin 10 mg Bitopertin Participants in Stratum 1 will receive bitopertin 10 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 10 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI.
- Primary Outcome Measures
Name Time Method Change From Baseline in Total Score on Yale-Brown Obsessive Compulsive Scale (Y-BOCS) After 12 Weeks of Treatment Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14
- Secondary Outcome Measures
Name Time Method Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score After 12 Weeks of Treatment Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14 Change From Baseline in Columbia Suicide Severity Rating Scale After 12 Weeks of Treatment Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 Change From Baseline in SF-36 - Physical Component Summary After 12 Weeks of Treatment Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 Area Under The Concentration-Time Curve of Bitopertin Pre-dose (0 hour) on Day 56 (Week 8), Day 84 (Week 12), Day 98 (Week 14), Day 112 (Week 16); 3 and 6 hours post-dose on Day 112 (Week 16) Percentage of Participants with Response as per Pre-defined Criteria Based on the Y-BOCS and CGI Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 Response will be defined as having:
At least a 35 percent (%) reduction on the total Y-BOCS score from baseline. A much or very much improved on the Clinical Global Impression of Change (CGI-C) rating from baseline.
A combination of at least 35% reduction on the total Y-BOCS score from baseline and much or very much improved on the CGI-C from baseline.
Achieved remission, as shown by a total Y-BOCS score less than or equal to (≤)10.Change From Baseline in Global Social Functioning Using Sheehan Disability Scale (SDS) Total Score After 12 Weeks of Treatment Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14 Change From Baseline in Obsessive Compulsive Inventory-Revised (OCI-R) Score After 12 Weeks of Treatment Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary After 12 Weeks of Treatment Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 Change From Baseline in Global Social Functioning Using SDS Domain Scores After 12 Weeks of Treatment Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14 Change From Baseline in SF-36 - Domain Scores After 12 Weeks of Treatment Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
Trial Locations
- Locations (33)
Keystone Clinical Studies, LLC
🇺🇸Norristown, Pennsylvania, United States
Compass Research North, LLC
🇺🇸Leesburg, Florida, United States
McMaster University - MacAnxiety Research Centre
🇨🇦Hamilton, Ontario, Canada
Mount Sinai School of Medicine; Department of Psychiatry
🇺🇸New York, New York, United States
True North Clinical Research-Halifax
🇨🇦Halifax, Nova Scotia, Canada
Chokka Center for Integrative Health
🇨🇦Edmonton, Alberta, Canada
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Eastside Therapeutic Resource
🇺🇸Kirkland, Washington, United States
FutureSearch Trials, LP
🇺🇸Austin, Texas, United States
Medical Research Network - New York
🇺🇸New York, New York, United States
True North Clinical Research Kentville
🇨🇦Kentville, Nova Scotia, Canada
North Star Research
🇺🇸Middleburg Heights, Ohio, United States
Uni of Chicago; Centre For Advanced Medicine
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital - East
🇺🇸Boston, Massachusetts, United States
Ambulatory Research Center (ARC), Department of Psychiatry
🇺🇸Minneapolis, Minnesota, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Ips Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Sunny Johnson Medical Research Associates Inc.; Medical Research Associates
🇨🇦Mississauga, Ontario, Canada
START Clinic for Mood & Anxiety Disorders
🇨🇦Toronto, Ontario, Canada
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Excell Research
🇺🇸Oceanside, California, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
Louisiana Research Associates
🇺🇸New Orleans, Louisiana, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Butler Hospital - Department of Psychiatry and Human Behavior
🇺🇸Providence, Rhode Island, United States
St Louis Clinical Trials
🇺🇸Saint Louis, Missouri, United States
Clinical Neuroscience Solutions,Inc
🇺🇸Memphis, Tennessee, United States
Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
Dean Foundation
🇺🇸Middleton, Wisconsin, United States
Yale University School of Medicine; Neuroscience Research Training Program
🇺🇸New Haven, Connecticut, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States