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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01674361
Other study ID # WN28137
Secondary ID
Status Completed
Phase Phase 2
First received August 15, 2012
Last updated July 31, 2017
Start date December 31, 2012
Est. completion date April 30, 2015

Study information

Verified date July 2017
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date April 30, 2015
Est. primary completion date April 30, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Canada Chokka Center for Integrative Health Edmonton Alberta
Canada True North Clinical Research-Halifax Halifax Nova Scotia
Canada McMaster University - MacAnxiety Research Centre Hamilton Ontario
Canada Okanagan Clinical Trials Kelowna British Columbia
Canada True North Clinical Research Kentville Kentville Nova Scotia
Canada Sunny Johnson Medical Research Associates Inc.; Medical Research Associates Mississauga Ontario
Canada START Clinic for Mood & Anxiety Disorders Toronto Ontario
United States FutureSearch Trials, LP Austin Texas
United States Boston Clinical Trials Boston Massachusetts
United States Massachusetts General Hospital - East Boston Massachusetts
United States Uni of Chicago; Centre For Advanced Medicine Chicago Illinois
United States iResearch Atlanta Decatur Georgia
United States Precise Research Centers Flowood Mississippi
United States Eastside Therapeutic Resource Kirkland Washington
United States Compass Research North, LLC Leesburg Florida
United States Clinical Neuroscience Solutions,Inc Memphis Tennessee
United States North Star Research Middleburg Heights Ohio
United States Dean Foundation Middleton Wisconsin
United States Ambulatory Research Center (ARC), Department of Psychiatry Minneapolis Minnesota
United States Yale University School of Medicine; Neuroscience Research Training Program New Haven Connecticut
United States Louisiana Research Associates New Orleans Louisiana
United States Medical Research Network - New York New York New York
United States Mount Sinai School of Medicine; Department of Psychiatry New York New York
United States Keystone Clinical Studies, LLC Norristown Pennsylvania
United States Excell Research Oceanside California
United States Ips Research Company Oklahoma City Oklahoma
United States Medical Research Group of Central Florida Orange City Florida
United States Butler Hospital - Department of Psychiatry and Human Behavior Providence Rhode Island
United States Finger Lakes Clinical Research Rochester New York
United States St Louis Clinical Trials Saint Louis Missouri
United States University of South Florida Saint Petersburg Florida
United States Carman Research Smyrna Georgia
United States Stanford University School of Medicine Stanford California
United States University of South Florida Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Percentage of Participants with Response as per Pre-defined Criteria Based on the Y-BOCS and CGI 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.
Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
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