A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Phase II, Multi-center, Randomized, 4-week, Double-blind, Parallel Group, Placebo and Active-controlled Trial of the Safety and Efficacy of RO4917838 vs. Placebo in Patients With an Acute Exacerbation of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234779
• Other study ID #: WN25333
• Secondary ID: 2010-021984-33
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2010
• Last updated: November 1, 2016
• Start date: February 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients, 18-65 years of age

• Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR)

• Acute exacerbation which began within the prior 8 weeks

• Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study

Exclusion Criteria:

• Current psychiatric diagnosis other than schizophrenia

• Alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)

• Electro-convulsive therapy (ECT) within the prior 6 months

• Previous treatment with RO4917838 or another GLYT inhibitor

• Current treatment with olanzapine, or previous treatment with intolerability or lack of response

• Treatment with long-acting injectable antipsychotic within 2 dosing intervals

• Treatment with > 2 antipsychotics within 3 months

• History of neuroleptic malignant syndrome

• Have treatment-resistant schizophrenia as judged by treating physician or have failed two trials according to criteria in protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• bitopertin [RO4917838]
10 mg orally daily, 4 weeks
• bitopertin [RO4917838]
30 mg orally daily, 4 weeks
• olanzapine
15 mg orally daily, 4 weeks
• placebo
orally daily, 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Romania,  Russian Federation,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Positive and Negative Syndrome Scale (PANSS) total score		from baseline to Day 28	No
Primary	Safety: Incidence adverse events		8 weeks	No
Secondary	Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score		from baseline to Day 28	No
Secondary	Change in symptomatology as measured by the PANSS factor and subscale scores		from baseline to Day 28	No
Secondary	Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale		from baseline to Day 28	No
Secondary	Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale		from baseline to Day 28	No
Secondary	Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)		from baseline to Day 28	No
Secondary	Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ)		from baseline to Day 28	No