A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
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ClinicalTrials.gov Identifier: NCT01674361 |
Recruitment Status
:
Completed
First Posted
: August 28, 2012
Last Update Posted
: August 2, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obsessive-Compulsive Disorder | Drug: Bitopertin Drug: Placebo Drug: SSRI | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | December 31, 2012 |
Actual Primary Completion Date : | April 30, 2015 |
Actual Study Completion Date : | April 30, 2015 |

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 Name: 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.
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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 Name: 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.
|
- 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 ]
- 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 ]
- Percentage of Participants with Response as per Pre-defined Criteria Based on the Y-BOCS and CGI [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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) ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674361

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01674361 History of Changes |
Other Study ID Numbers: |
WN28137 |
First Posted: | August 28, 2012 Key Record Dates |
Last Update Posted: | August 2, 2017 |
Last Verified: | July 2017 |
Additional relevant MeSH terms:
Disease Compulsive Personality Disorder Obsessive-Compulsive Disorder Pathologic Processes Personality Disorders Mental Disorders Anxiety Disorders Serotonin |
Serotonin Uptake Inhibitors Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |