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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01674361

Collaborator

(none)

Enrollment

Locations

Arms

27.9

Actual Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Drug: Bitopertin Drug: Placebo Drug: SSRI	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 31, 2012

Actual Primary Completion Date :

Apr 30, 2015

Actual Study Completion Date :

Apr 30, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Bitopertin Bitopertin once daily orally. Other Names: RO4917838 Drug: Placebo Placebo matched to bitopertin once daily orally. Drug: 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.
Experimental: 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.	Drug: Bitopertin Bitopertin once daily orally. Other Names: RO4917838 Drug: Placebo Placebo matched to bitopertin once daily orally. Drug: 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 Comparator: 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.	Drug: Placebo Placebo matched to bitopertin once daily orally. Drug: 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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Bitopertin

Bitopertin once daily orally.

Other Names:

RO4917838

Drug: Placebo

Placebo matched to bitopertin once daily orally.

Drug: 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.

Experimental: 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.

Drug: Bitopertin

Bitopertin once daily orally.

Other Names:

RO4917838

Drug: Placebo

Placebo matched to bitopertin once daily orally.

Drug: SSRI

Placebo Comparator: 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.

Drug: Placebo

Placebo matched to bitopertin once daily orally.

Drug: SSRI

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
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 [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]
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]
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]
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]
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]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Excell Research	Oceanside	California	United States	92056
2	Stanford University School of Medicine	Stanford	California	United States	94305
3	Yale University School of Medicine; Neuroscience Research Training Program	New Haven	Connecticut	United States	06519
4	Compass Research North, LLC	Leesburg	Florida	United States	34748
5	Medical Research Group of Central Florida	Orange City	Florida	United States	3273
6	University of South Florida	Saint Petersburg	Florida	United States	33701
7	University of South Florida	Tampa	Florida	United States	33613-4706
8	iResearch Atlanta	Decatur	Georgia	United States	30030
9	Carman Research	Smyrna	Georgia	United States	30080
10	Uni of Chicago; Centre For Advanced Medicine	Chicago	Illinois	United States	60637
11	Louisiana Research Associates	New Orleans	Louisiana	United States	70114
12	Massachusetts General Hospital - East	Boston	Massachusetts	United States	02114
13	Boston Clinical Trials	Boston	Massachusetts	United States	02131
14	Ambulatory Research Center (ARC), Department of Psychiatry	Minneapolis	Minnesota	United States	55454
15	Precise Research Centers	Flowood	Mississippi	United States	39232
16	St Louis Clinical Trials	Saint Louis	Missouri	United States	63141
17	Mount Sinai School of Medicine; Department of Psychiatry	New York	New York	United States	10029
18	Medical Research Network - New York	New York	New York	United States	10128
19	Finger Lakes Clinical Research	Rochester	New York	United States	14618
20	North Star Research	Middleburg Heights	Ohio	United States	44130
21	Ips Research Company	Oklahoma City	Oklahoma	United States	73103
22	Keystone Clinical Studies, LLC	Norristown	Pennsylvania	United States	19403
23	Butler Hospital - Department of Psychiatry and Human Behavior	Providence	Rhode Island	United States	02906
24	Clinical Neuroscience Solutions,Inc	Memphis	Tennessee	United States	38119
25	FutureSearch Trials, LP	Austin	Texas	United States	78731
26	Eastside Therapeutic Resource	Kirkland	Washington	United States	98033
27	Dean Foundation	Middleton	Wisconsin	United States	53562
28	Chokka Center for Integrative Health	Edmonton	Alberta	Canada	T6L 6W6
29	Okanagan Clinical Trials	Kelowna	British Columbia	Canada	V1Y 2H4
30	True North Clinical Research-Halifax	Halifax	Nova Scotia	Canada	B3S 1M7
31	True North Clinical Research Kentville	Kentville	Nova Scotia	Canada	B4N 4K9
32	McMaster University - MacAnxiety Research Centre	Hamilton	Ontario	Canada	L8S 1B7
33	Sunny Johnson Medical Research Associates Inc.; Medical Research Associates	Mississauga	Ontario	Canada	L5M 4N4
34	START Clinic for Mood & Anxiety Disorders	Toronto	Ontario	Canada	M4W 2N4

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01674361

Other Study ID Numbers:

WN28137

First Posted:

Aug 28, 2012

Last Update Posted:

Aug 2, 2017

Last Verified:

Jul 1, 2017

Additional relevant MeSH terms:

Compulsive Personality Disorder

Obsessive-Compulsive Disorder

Study Results

No Results Posted as of Aug 2, 2017