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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01674361
First Posted: August 28, 2012
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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 Intervention Phase
Obsessive-Compulsive Disorder Drug: Bitopertin Drug: Placebo Drug: SSRI Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 99
Actual Study Start Date: December 31, 2012
Study Completion Date: April 30, 2015
Primary Completion Date: April 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

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


  Show 34 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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
First Submitted: August 15, 2012
First Posted: August 28, 2012
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