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

August 15, 2012
April 30, 2013
December 2012
November 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01674361 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors in Patients With Obsessive-Compulsive Disorder
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
  • Drug: bitopertin
    30 mg (Arm A) or 10 mg (Arm B) orally daily, 16 weeks
  • Drug: placebo
    orally daily, 16 weeks
  • Experimental: A: Bitopertin 30 mg
    Intervention: Drug: bitopertin
  • Experimental: B: Bitopertin 10 mg
    Intervention: Drug: bitopertin
  • Experimental: C: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
99
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Please reference Study ID Number: WN28137 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
United States
 
NCT01674361
WN28137
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP