A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Combination With Selective Serotonin Reuptake Inhibitors in Patients With Obsessive Compulsive Disorder
1 other identifier
interventional
99
2 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2012
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 28, 2012
CompletedStudy Start
First participant enrolled
December 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2015
CompletedAugust 2, 2017
July 1, 2017
2.3 years
August 15, 2012
July 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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
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
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 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 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
- +5 more secondary outcomes
Study Arms (3)
Bitopertin 30 mg
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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 COMPARATORParticipants (both Stratum 1 and Stratum 2) will receive placebo from Day 1 to Week 16 in addition to their background therapy with an SSRI.
Interventions
Participants will continue their background SSRI treatment as per standard of care at the same dose taken during the 8 weeks prior to Day 1. Protocol does not enforce any particular SSRI drug or regimen.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Excell Research
Oceanside, California, 92056, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Yale University School of Medicine; Neuroscience Research Training Program
New Haven, Connecticut, 06519, United States
Compass Research North, LLC
Leesburg, Florida, 34748, United States
Medical Research Group of Central Florida
Orange City, Florida, 3273, United States
University of South Florida
St. Petersburg, Florida, 33701, United States
University of South Florida
Tampa, Florida, 33613-4706, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Carman Research
Smyrna, Georgia, 30080, United States
Uni of Chicago; Centre For Advanced Medicine
Chicago, Illinois, 60637, United States
Louisiana Research Associates
New Orleans, Louisiana, 70114, United States
Massachusetts General Hospital - East
Boston, Massachusetts, 02114, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Ambulatory Research Center (ARC), Department of Psychiatry
Minneapolis, Minnesota, 55454, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
St Louis Clinical Trials
St Louis, Missouri, 63141, United States
Mount Sinai School of Medicine; Department of Psychiatry
New York, New York, 10029, United States
Medical Research Network - New York
New York, New York, 10128, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
North Star Research
Middleburg Heights, Ohio, 44130, United States
Ips Research Company
Oklahoma City, Oklahoma, 73103, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19403, United States
Butler Hospital - Department of Psychiatry and Human Behavior
Providence, Rhode Island, 02906, United States
Clinical Neuroscience Solutions,Inc
Memphis, Tennessee, 38119, United States
FutureSearch Trials, LP
Austin, Texas, 78731, United States
Eastside Therapeutic Resource
Kirkland, Washington, 98033, United States
Dean Foundation
Middleton, Wisconsin, 53562, United States
Chokka Center for Integrative Health
Edmonton, Alberta, T6L 6W6, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 2H4, Canada
True North Clinical Research-Halifax
Halifax, Nova Scotia, B3S 1M7, Canada
True North Clinical Research Kentville
Kentville, Nova Scotia, B4N 4K9, Canada
McMaster University - MacAnxiety Research Centre
Hamilton, Ontario, L8S 1B7, Canada
Sunny Johnson Medical Research Associates Inc.; Medical Research Associates
Mississauga, Ontario, L5M 4N4, Canada
START Clinic for Mood & Anxiety Disorders
Toronto, Ontario, M4W 2N4, Canada
Related Publications (1)
Bandeira ID, Lins-Silva DH, Cavenaghi VB, Dorea-Bandeira I, Faria-Guimaraes D, Barouh JL, Jesus-Nunes AP, Beanes G, Souza LS, Leal GC, Sanacora G, Miguel EC, Sampaio AS, Quarantini LC. Ketamine in the Treatment of Obsessive-Compulsive Disorder: A Systematic Review. Harv Rev Psychiatry. 2022 Mar-Apr 01;30(2):135-145. doi: 10.1097/HRP.0000000000000330.
PMID: 35267254DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2012
First Posted
August 28, 2012
Study Start
December 31, 2012
Primary Completion
April 30, 2015
Study Completion
April 30, 2015
Last Updated
August 2, 2017
Record last verified: 2017-07