A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

November 1, 2016 updated by: Hoffmann-La Roche

Phase III, Multi-center, Randomized, 12-week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 40-week Double-blind, Parallel-group, Placebo-controlled Treatment Period.

This randomized, multi-center double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

604

Phase

  • Phase 3

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

  • Bulgaria
      • Bourgas, Bulgaria, 8000
      • Kazanlak, Bulgaria, 6100
      • Novi Iskar, Bulgaria, 1282
      • Pazardzhik, Bulgaria, 4400
      • Plovdiv, Bulgaria, 4002
      • Radnevo, Bulgaria, 6260
      • Rousse, Bulgaria, 7003
      • Sofia, Bulgaria, 1606
  • China
      • Baoding, China, 071000
      • Beijing, China, 100083
      • Beijing, China, 100088
      • Beijing, China, 071000
      • Changsha, China, 410011
      • Chengdu, China, 610041
      • GuangzhouGuangdong, China, 510370
      • Hangzhou, China, 310003
      • Kunming, China, 650032
      • Nanjing, China, 210029
      • Shanghai, China, 200030
      • Shanghai, China, 200065
      • Wuhan, China, 430060
      • Wuxi, China, 214151
      • Xi'an, China, 710032
      • Xi'an, China, 710061
  • Czech Republic
      • Brno, Czech Republic, 602 00
      • Liberec, Czech Republic, 460 63
      • Melnik, Czech Republic, 276 01
      • Plzen, Czech Republic, 312 00
      • Praha 10, Czech Republic, 100 00
      • Praha 6, Czech Republic, 160 00
      • Praha 8 - Bohnice, Czech Republic, 181 03
      • Sternberk, Czech Republic, 785 01
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
      • Milano, Lombardia, Italy, 20122
      • Milano, Lombardia, Italy, 20121
    • Piemonte
      • Torino, Piemonte, Italy, 10126
    • Puglia
      • Bari, Puglia, Italy, 70124
    • Toscana
      • Pisa, Toscana, Italy, 56124
      • Pisa, Toscana, Italy, 56126
    • Veneto
      • Padova, Veneto, Italy, 35128
  • Japan
      • Chiba, Japan, 272-8516
      • Funabashi-shi, Japan, 273-8540
      • Gunma, Japan, 370-2455
      • Hiroshima-shi, Japan, 733-0864
      • Hokkaido, Japan, 060-8648
      • Kanzaki-gun, Japan, 842-0192
      • Kita-Ku, Japan, 114-0024
      • Kitakyushu-shi, Japan, 807-8556
      • Kochi-shi, Japan, 780-8535
      • Koshi-shi, Japan, 861-1116
      • Kumamoto-shi, Japan, 861-8002
      • Kurayoshi-shi, Japan, 682-0023
      • Nagoya-Shi, Japan, 463-0802
      • Omuta-shi, Japan, 836-0004
      • Sakai-shi, Japan, 590-0018
      • Sapporo-shi, Japan, 004-0841
      • Sapporo-shi, Japan, 006-0816
      • Sendai-shi, Japan, 983-0836
      • Shirakawa-shi, Japan, 961-0021
      • Tokyo, Japan, 187-8551
      • Tokyo, Japan, 162-8666
      • Toyama-shi, Japan, 939-8073
      • Toyoake-shi, Japan, 470-1192
      • Yokohama-shi, Japan, 223-0062
      • Yokohama-shi, Japan, 233-0006
      • Yokohama-shi, Japan, 246-0026
  • Russian Federation
      • St. Petersburg, Russian Federation, 190121
  • United States
    • California
      • Costa Mesa, California, United States, 92626
      • Escondido, California, United States, 92025
      • Granada Hills, California, United States, 91344
      • La Jolla, California, United States, 92093
      • Oceanside, California, United States, 92056
      • San Diego, California, United States, 92103
      • Torrance, California, United States, 90502
    • Florida
      • Lauderhill, Florida, United States, 33319
      • Orange City, Florida, United States, 3273
      • Plantation, Florida, United States, 33317
    • Georgia
      • Atlanta, Georgia, United States, 30308
    • Indiana
      • Indianapolis, Indiana, United States, 46222
    • Mississippi
      • Flowood, Mississippi, United States, 39232
    • Nevada
      • Las Vegas, Nevada, United States, 89102
    • New York
      • Buffalo, New York, United States, 14215
      • New York, New York, United States, 10032
      • Rochester, New York, United States, 14618
    • North Carolina
      • Durham, North Carolina, United States, 27705
    • Pennsylvania
      • Scranton, Pennsylvania, United States, 18503
    • Texas
      • Austin, Texas, United States, 78754
      • Irving, Texas, United States, 75062
    • Utah
      • Salt Lake City, Utah, United States, 84106

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Diagnosis of schizophrenia
  • Clinical stability for 16 weeks (4 months) prior to randomization
  • Antipsychotic treatment stability for the past 12 weeks prior to randomization
  • With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)

Exclusion Criteria:

  • Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
  • Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
  • Patient has a body mass index (BMI) of <17 or >40 kg/m2, respectively)
  • Diagnosis of mental retardation or severe organic brain syndromes
  • In the investigator's judgment, a significant risk of suicide or violent behavior"

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
Placebo Comparator: Placebo
Drug: Placebo
Oral doses, once a day for 52 weeks
Experimental: bitopertin [RO4917838] 1
Drug: bitopertin [RO4917838] level 1
Oral dose level 1, once a day for 52 weeks
Experimental: bitopertin [RO4917838] 2
Drug: bitopertin [RO4917838] level 2
Oral dose level 2, once a day for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)
Time Frame: Change from baseline to Week 12
Change from baseline to Week 12
Safety (incidence of adverse events)
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)
Time Frame: Change from baseline to Week 12
Change from baseline to Week 12
Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale
Time Frame: Change from baseline to Week 12
Change from baseline to Week 12
Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale
Time Frame: Change from baseline to Week 12
Change from baseline to Week 12
Safety (incidence of adverse events)
Time Frame: 60 weeks
60 weeks

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

November 4, 2010

First Posted (Estimate)

November 5, 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

  • WN25305
  • 2010-020718-26

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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