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

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:

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 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:


Obsessive-Compulsive Disorder Compulsive Personality Disorder Anxiety Disorders Mental Disorders 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 February 27, 2015