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

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:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Serotonin

U.S. FDA Resources

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


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

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

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
Study First Received:	August 15, 2012
Last Updated:	July 31, 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

ClinicalTrials.gov processed this record on August 23, 2017