A Study to Evaluate Efficacy and Safety of Bitopertin in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This Phase 3, multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

Key facts

Study ID: NCT01192880
Run by: Hoffmann-La Roche
People needed: 625
Starts: 2010-11-01
Expected to finish: 2014-07-01
Last updated by the study team: 2017-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Based on the screening Structured Clinical Interview for and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) - Clinical Trial (SCID CT), a DSM-IV- Text Revision (DSM-IV-TR) diagnosis of schizophrenia, paranoid, disorganized, residual, undifferentiated or catatonic subtype
A score of 40 or greater on the sum of the 14 PANSS negative and disorganized thought factor items (items scored 1-7 for a maximum possible score of 98)
A score of 22 or less on the sum of the 8 PANSS positive symptom factor items. The score of the items of P1 (delusions), P3 (hallucinatory behavior), P6 (suspiciousness) and G9 (unusual thought content) meet the following requirements: no more than 2 of the above items have a score of 4; all of the above items score less than 5
Clinical stability for 6 months prior to randomization as well as antipsychotic treatment stability for the past 8 weeks at the time of randomization
Are at least moderately ill, as defined by Clinical Global Impression - Severity (CGI S) of negative symptoms score more than or equal to (>/=) 4
Stable doses of anticholinergic, antidepressive medication for at least 8 weeks prior to randomization is allowed as long as the respective scales cut-off entry criteria are met
With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of 2 antipsychotics)
Have a caregiver considered reliable by the investigator
Female participants who are not either surgically sterile or post-menopausal must agree to use at least one effective forms of contraception from agree to remain sexually abstinent from screening until 90 days after the completion of the study medication

You may not qualify if…

Evidence that participant has clinically significant, uncontrolled and unstable disorder (for example, cardiovascular, renal, hepatic disorder)
Body Mass Index (BMI) of less than (<) 17 or more than (>) 40 kilograms per meter square (kg/m\^2)
Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
A severity score of >/=3 on the Parkinsonism item of the Extrapyramidal Symptoms Rating Scale - Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism)
Positive result on the serum pregnancy test or are breast feeding at screening, or intend to become pregnant during the course of the trial.
History of neuroleptic malignant syndrome (NMS)
Based on the DSM-IV-TR criteria and screening SCID-CT have: other current DSM-IV-TR Axis I diagnosis; alcohol or substance dependence within 12 months or abuse within 3 months with the exception of nicotine; dementia, delirium and other amnestic disorder per DSM-IV-TR
Treated with electroconvulsive therapy (ECT) within 6 months prior to randomization
Ever received RO4917838 or another glycine transporter 1 (GLYT 1) inhibitor
Require high doses of benzodiazepines (> 4 mg per day lorazepam or equivalent)
Have a positive urine drug screen for amphetamines (including 3,4-Methylenedioxymethamphetamine [MDMA]/ecstasy), cocaine, barbiturate, cannabis and/or opiates

Where it is running

Synergy Clinical Research of Escondido — Escondido, California, United States
San Fernando Mental Health Center — Granada Hills, California, United States
University of California San Diego — La Jolla, California, United States
Excell Research — Oceanside, California, United States
Artemis Institute for Clinical Research, LLC — San Diego, California, United States
Collaborative Neuroscience Network Inc. — Torrance, California, United States
Behavioral Clinical Research Inc. — Lauderhill, Florida, United States
University of Miami Miller School of Medicine — Miami, Florida, United States
Medical Research Group of Central Florida — Orange City, Florida, United States
Berma Research Group — Plantation, Florida, United States
Atlanta Center For Medical Research — Atlanta, Georgia, United States
Indiana University; LaRue Carter Memorial Hospital-Research Unit — Indianapolis, Indiana, United States
Clinical Insights, Inc. — Glen Burnie, Maryland, United States
Precise Research Centers — Flowood, Mississippi, United States
Altea Research Institute — Las Vegas, Nevada, United States
Ocean Rheumatology — Toms River, New Jersey, United States
State University of New York at Buffalo; Department of Psychiatry — Buffalo, New York, United States
New York State Psychiatric Institute; Psychiatry Dept of Columbia University — New York, New York, United States
Finger Lakes Clinical Research — Rochester, New York, United States
Duke University — Durham, North Carolina, United States
Keystone Clinical Studies, LLC — Norristown, Pennsylvania, United States
Scranton Medical Institutes Llc. — Scranton, Pennsylvania, United States
Community Clinical Research Inc. — Austin, Texas, United States
University Hills Clinical Research — Irving, Texas, United States
Clinical Innovtions Inc — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

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