A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
NCT ID: NCT01674361
Last Updated: 2017-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2012-12-31
2015-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
NCT00211744
Treatment of Hypochondriasis With CBT and/or SSRI
NCT00339079
Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
NCT04708834
Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder
NCT03299166
Assisting Obsessive Compulsive Disorder (OCD) Patients With Discontinuing Long-term Serotonin Reuptake Inhibitors (SRIs)
NCT02103621
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bitopertin 30 mg
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
Bitopertin once daily orally.
Placebo
Placebo matched to bitopertin once daily orally.
SSRI
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.
Bitopertin 10 mg
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
Bitopertin once daily orally.
Placebo
Placebo matched to bitopertin once daily orally.
SSRI
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.
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
Placebo matched to bitopertin once daily orally.
SSRI
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bitopertin
Bitopertin once daily orally.
Placebo
Placebo matched to bitopertin once daily orally.
SSRI
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Excell Research
Oceanside, California, United States
Stanford University School of Medicine
Stanford, California, United States
Yale University School of Medicine; Neuroscience Research Training Program
New Haven, Connecticut, United States
Compass Research North, LLC
Leesburg, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
University of South Florida
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
iResearch Atlanta
Decatur, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Uni of Chicago; Centre For Advanced Medicine
Chicago, Illinois, United States
Louisiana Research Associates
New Orleans, Louisiana, United States
Massachusetts General Hospital - East
Boston, Massachusetts, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Ambulatory Research Center (ARC), Department of Psychiatry
Minneapolis, Minnesota, United States
Precise Research Centers
Flowood, Mississippi, United States
St Louis Clinical Trials
St Louis, Missouri, United States
Mount Sinai School of Medicine; Department of Psychiatry
New York, New York, United States
Medical Research Network - New York
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
North Star Research
Middleburg Heights, Ohio, United States
Ips Research Company
Oklahoma City, Oklahoma, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States
Butler Hospital - Department of Psychiatry and Human Behavior
Providence, Rhode Island, United States
Clinical Neuroscience Solutions,Inc
Memphis, Tennessee, United States
FutureSearch Trials, LP
Austin, Texas, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Dean Foundation
Middleton, Wisconsin, United States
Chokka Center for Integrative Health
Edmonton, Alberta, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
True North Clinical Research-Halifax
Halifax, Nova Scotia, Canada
True North Clinical Research Kentville
Kentville, Nova Scotia, Canada
McMaster University - MacAnxiety Research Centre
Hamilton, Ontario, Canada
Sunny Johnson Medical Research Associates Inc.; Medical Research Associates
Mississauga, Ontario, Canada
START Clinic for Mood & Anxiety Disorders
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WN28137
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.