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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Hoffmann-La Roche.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: August 15, 2012
Last updated: April 30, 2013
Last verified: April 2013
This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of bitopertin (RO4917838) in combination with selective serotonin reuptake inhibitors (SSRI) in patients with obsessive-compulsive disorder. Patients will be randomized to receive either bitopertin 30 mg or bitopertin 10 mg or placebo orally daily in addition to their background therapy with an SSRI. Anticipated time on study treatment is 16 weeks.

Condition Intervention Phase
Obsessive-Compulsive Disorder
Drug: bitopertin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in total score on Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: in 12 weeks between baseline and Week 16 ]

Secondary Outcome Measures:
  • Change in Clinical Global Impression of Severity (CGI-S) score [ Time Frame: in 12 weeks between baseline and Week 16 ]
  • Rate of responders according to changes in Y-BOCS and CGI-C [ Time Frame: in 12 weeks between baseline and Week 16 ]
  • Change in global social functioning: Sheehan Disability Scale (SDS) [ Time Frame: in 12 weeks between baseline and Week 16 ]
  • Change in Obsessive Compulsive Inventory-Revised (OCI-R) score [ Time Frame: in 12 weeks between baseline and Week 16 ]
  • Safety: Incidence of adverse events [ Time Frame: in 12 weeks between baseline and Week 16 ]

Estimated Enrollment: 99
Study Start Date: December 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Bitopertin 30 mg Drug: bitopertin
30 mg (Arm A) or 10 mg (Arm B) orally daily, 16 weeks
Experimental: B: Bitopertin 10 mg Drug: bitopertin
30 mg (Arm A) or 10 mg (Arm B) orally daily, 16 weeks
Experimental: C: Placebo Drug: placebo
orally daily, 16 weeks


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

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age
  • Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
  • On a stable dose of selective serotonin reuptake inhibitor (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 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 one augmentation therapy or have had more than one augmentation therapy used in conjunction with an SSRI
  • Recently initiated (within the last 6 months) or current behavioral therapy (cognitive behavioral therapy or exposure response prevention therapy)
  • 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
  • Any eating disorder within the last 6 months
  • History od substance dependence and/or substance abuse in the last 6 months, with the exception of nicotine
  • Previous treatment with bitopertin or another GlyT-1 inhibitor
  • Positive urine drug screening for cannabis, amphetamines (including MDMA/ecstasy), cocaine, barbiturate, and/or opiates
  • Prior or current general medical condition that may impair cognition or other neuropsychiatric functioning
  • Body mass index <18.5 kg/m2 or >40 kg/m2
  • Pregnant or lactating women
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01674361

United States, California
Oceanside, California, United States, 92056
Stanford, California, United States, 94305-2200
United States, Connecticut
New Haven, Connecticut, United States, 06519
United States, Florida
Saint Petersburg, Florida, United States, 33701
Tampa, Florida, United States, 33613
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Minnesota
Minneapolis, Minnesota, United States, 55454
United States, Missouri
St Louis, Missouri, United States, 63118
United States, New York
New York, New York, United States, 10029
Rochester, New York, United States, 14618
United States, Pennsylvania
Norristown, Pennsylvania, United States, 19403
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, Tennessee
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01674361     History of Changes
Other Study ID Numbers: WN28137 
Study First Received: August 15, 2012
Last Updated: April 30, 2013

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior
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

ClinicalTrials.gov processed this record on January 23, 2017