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



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:2/16/2017
Start Date:November 2010
End Date:July 2014

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A Phase III, Multi-Center, Randomized, 24 Week, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-Blind Treatment Period

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
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Kirkland, Washington 98033
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Durham, North Carolina 27710
(919) 684-8111
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1601 Northwest 12th Avenue
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3838 South 700 East
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811 Juniper St NE
Atlanta, Georgia 30308
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Austin, Texas 78754
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1675 Scenic Ave # 100
Costa Mesa, California 92626
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Escondido, California 92025
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Flowood, Mississippi 39232
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9500 Gilman Dr
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4101 NW 4th St # 208
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Scranton, Pennsylvania 18503
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