Back to resultsA Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bitopertin
Placebo
SSRI
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
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
Sites / Locations
- Excell Research
- Stanford University School of Medicine
- Yale University School of Medicine; Neuroscience Research Training Program
- Compass Research North, LLC
- Medical Research Group of Central Florida
- University of South Florida
- University of South Florida
- iResearch Atlanta
- Carman Research
- Uni of Chicago; Centre For Advanced Medicine
- Louisiana Research Associates
- Massachusetts General Hospital - East
- Boston Clinical Trials
- Ambulatory Research Center (ARC), Department of Psychiatry
- Precise Research Centers
- St Louis Clinical Trials
- Mount Sinai School of Medicine; Department of Psychiatry
- Medical Research Network - New York
- Finger Lakes Clinical Research
- North Star Research
- Ips Research Company
- Keystone Clinical Studies, LLC
- Butler Hospital - Department of Psychiatry and Human Behavior
- Clinical Neuroscience Solutions,Inc
- FutureSearch Trials, LP
- Eastside Therapeutic Resource
- Dean Foundation
- Chokka Center for Integrative Health
- Okanagan Clinical Trials
- True North Clinical Research-Halifax
- True North Clinical Research Kentville
- McMaster University - MacAnxiety Research Centre
- Sunny Johnson Medical Research Associates Inc.; Medical Research Associates
- START Clinic for Mood & Anxiety Disorders
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Bitopertin 30 mg
Bitopertin 10 mg
Placebo
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Change From Baseline in Total Score on Yale-Brown Obsessive Compulsive Scale (Y-BOCS) After 12 Weeks of Treatment
Secondary Outcome Measures
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score After 12 Weeks of Treatment
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.
Change From Baseline in Global Social Functioning Using Sheehan Disability Scale (SDS) Total Score After 12 Weeks of Treatment
Change From Baseline in Global Social Functioning Using SDS Domain Scores After 12 Weeks of Treatment
Change From Baseline in Obsessive Compulsive Inventory-Revised (OCI-R) Score After 12 Weeks of Treatment
Change From Baseline in Columbia Suicide Severity Rating Scale After 12 Weeks of Treatment
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary After 12 Weeks of Treatment
Change From Baseline in SF-36 - Physical Component Summary After 12 Weeks of Treatment
Change From Baseline in SF-36 - Domain Scores After 12 Weeks of Treatment
Area Under The Concentration-Time Curve of Bitopertin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01674361
Brief Title
A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 31, 2012 (Actual)
Primary Completion Date
April 30, 2015 (Actual)
Study Completion Date
April 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bitopertin 30 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Bitopertin 10 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bitopertin
Other Intervention Name(s)
RO4917838
Intervention Description
Bitopertin once daily orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to bitopertin once daily orally.
Intervention Type
Drug
Intervention Name(s)
SSRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Total Score on Yale-Brown Obsessive Compulsive Scale (Y-BOCS) After 12 Weeks of Treatment
Time Frame
Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score After 12 Weeks of Treatment
Time Frame
Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14
Title
Percentage of Participants with Response as per Pre-defined Criteria Based on the Y-BOCS and CGI
Description
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.
Time Frame
Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
Title
Change From Baseline in Global Social Functioning Using Sheehan Disability Scale (SDS) Total Score After 12 Weeks of Treatment
Time Frame
Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14
Title
Change From Baseline in Global Social Functioning Using SDS Domain Scores After 12 Weeks of Treatment
Time Frame
Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
Title
Change From Baseline in Obsessive Compulsive Inventory-Revised (OCI-R) Score After 12 Weeks of Treatment
Time Frame
Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
Title
Change From Baseline in Columbia Suicide Severity Rating Scale After 12 Weeks of Treatment
Time Frame
Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary After 12 Weeks of Treatment
Time Frame
Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
Title
Change From Baseline in SF-36 - Physical Component Summary After 12 Weeks of Treatment
Time Frame
Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
Title
Change From Baseline in SF-36 - Domain Scores After 12 Weeks of Treatment
Time Frame
Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14
Title
Area Under The Concentration-Time Curve of Bitopertin
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale University School of Medicine; Neuroscience Research Training Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Compass Research North, LLC
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
3273
Country
United States
Facility Name
University of South Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-4706
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Uni of Chicago; Centre For Advanced Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Louisiana Research Associates
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Massachusetts General Hospital - East
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Ambulatory Research Center (ARC), Department of Psychiatry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
St Louis Clinical Trials
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mount Sinai School of Medicine; Department of Psychiatry
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Medical Research Network - New York
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
North Star Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Ips Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Keystone Clinical Studies, LLC
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
Butler Hospital - Department of Psychiatry and Human Behavior
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Clinical Neuroscience Solutions,Inc
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Trials, LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Dean Foundation
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Chokka Center for Integrative Health
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 6W6
Country
Canada
Facility Name
Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
True North Clinical Research-Halifax
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1M7
Country
Canada
Facility Name
True North Clinical Research Kentville
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
Country
Canada
Facility Name
McMaster University - MacAnxiety Research Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1B7
Country
Canada
Facility Name
Sunny Johnson Medical Research Associates Inc.; Medical Research Associates
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 4N4
Country
Canada
Facility Name
START Clinic for Mood & Anxiety Disorders
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
35267254
Citation
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.
Results Reference
derived
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A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
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