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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01674361
First received: August 15, 2012
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Clinical Global Impression of Severity (CGI-S) score [ Time Frame: in 12 weeks between baseline and Week 16 ] [ Designated as safety issue: No ]
  • Rate of responders according to changes in Y-BOCS and CGI-C [ Time Frame: in 12 weeks between baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change in global social functioning: Sheehan Disability Scale (SDS) [ Time Frame: in 12 weeks between baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change in Obsessive Compulsive Inventory-Revised (OCI-R) score [ Time Frame: in 12 weeks between baseline and Week 16 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: in 12 weeks between baseline and Week 16 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674361

Contacts
Contact: Please reference Study ID Number: WN28137 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
United States, California
Recruiting
Oceanside, California, United States, 92056
Recruiting
Stanford, California, United States, 94305-2200
United States, Connecticut
Recruiting
New Haven, Connecticut, United States, 06519
United States, Florida
Recruiting
Saint Petersburg, Florida, United States, 33701
Recruiting
Tampa, Florida, United States, 33613
United States, Illinois
Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States, 55454
United States, Missouri
Recruiting
St Louis, Missouri, United States, 63118
United States, New York
Recruiting
New York, New York, United States, 10029
Active, not recruiting
Rochester, New York, United States, 14618
United States, Pennsylvania
Recruiting
Norristown, Pennsylvania, United States, 19403
United States, Rhode Island
Recruiting
Providence, Rhode Island, United States, 02906
United States, Tennessee
Recruiting
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Compulsive Personality Disorder
Disease
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Pathologic Processes
Personality Disorders
Serotonin Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents

ClinicalTrials.gov processed this record on November 27, 2014