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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Arad, Romania, 310022
      • Bucuresti, Romania, 041902
      • Bucuresti, Romania, 010825
      • Bucuresti, Romania, 041914
      • Foscani, Romania, 620165
      • Oradea, Romania, 410154
      • Targoviste, Romania, 130086
  • Russian Federation
      • Gatchina, Russian Federation, 188357
      • Moscow, Russian Federation, 117152
      • Petrozavodsk, Russian Federation, 186131
      • St Petersburg, Russian Federation, 194044
      • St Petersburg, Russian Federation, 190005
      • St Petersburg, Russian Federation, 193167
      • St Petersburg, Russian Federation, 197341
      • St. Petersburg, Russian Federation, 192019
      • Talagi, Russian Federation, 163530
  • Slovakia
      • Bojnice, Slovakia, 972 01
      • Bratislava, Slovakia, 826 06
      • Liptovsky Mikulas, Slovakia, 3123
      • Michalovce, Slovakia, 071 01
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49027
      • Donetsk, Ukraine, 83008
      • Kherson,Vil. Stepanivka, Ukraine, 73488
      • Kyiv, Ukraine, 02660
      • Kyiv, Ukraine, 04080
      • Poltava, Ukraine, 36006
      • Vinnytsya, Ukraine, 21005
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
    • California
      • Cerritos, California, United States, 90703
      • Oceanside, California, United States, 92056
      • Pico Rivera, California, United States, 90660
      • San Diego, California, United States, 92121
    • Florida
      • Lauderhill, Florida, United States, 33021
      • North Miami, Florida, United States, 33161
    • Georgia
      • Atlanta, Georgia, United States, 30308
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
    • Mississippi
      • Flowood, Mississippi, United States, 39232
    • Missouri
      • St. Louis, Missouri, United States, 63141
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
    • New York
      • Holliswood, New York, United States, 11423
      • New York, New York, United States, 11004
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
    • South Carolina
      • Charlesston, South Carolina, United States, 29405
    • Texas
      • Austin, Texas, United States, 78754
      • Irving, Texas, United States, 75062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: bitopertin [RO4917838]
10 mg orally daily, 4 weeks
Drug: bitopertin [RO4917838]
30 mg orally daily, 4 weeks
Experimental: B
Drug: bitopertin [RO4917838]
10 mg orally daily, 4 weeks
Drug: bitopertin [RO4917838]
30 mg orally daily, 4 weeks
Active Comparator: C
Drug: olanzapine
15 mg orally daily, 4 weeks
Placebo Comparator: D
Drug: placebo
orally daily, 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Positive and Negative Syndrome Scale (PANSS) total score
Time Frame: from baseline to Day 28
from baseline to Day 28
Safety: Incidence adverse events
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score
Time Frame: from baseline to Day 28
from baseline to Day 28
Change in symptomatology as measured by the PANSS factor and subscale scores
Time Frame: from baseline to Day 28
from baseline to Day 28
Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale
Time Frame: from baseline to Day 28
from baseline to Day 28
Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale
Time Frame: from baseline to Day 28
from baseline to Day 28
Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)
Time Frame: from baseline to Day 28
from baseline to Day 28
Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ)
Time Frame: from baseline to Day 28
from baseline to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WN25333
  • 2010-021984-33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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