A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674361
• Other study ID #: WN28137
• 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
• 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

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder

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)