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

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ClinicalTrials.gov Identifier: NCT01235559
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Placebo Drug: bitopertin [RO4917838] level 1 Drug: bitopertin [RO4917838] level 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : December 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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




Primary Outcome Measures :
  1. Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from baseline to Week 12 ]
  2. Safety (incidence of adverse events) [ Time Frame: Week 12 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235559


  Hide Study Locations
Locations
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
United States, Florida
Lauderhill, Florida, United States, 33319
Orange City, Florida, United States, 3273
Plantation, Florida, United States, 33317
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Indiana
Indianapolis, Indiana, United States, 46222
United States, Mississippi
Flowood, Mississippi, United States, 39232
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, New York
Buffalo, New York, United States, 14215
New York, New York, United States, 10032
Rochester, New York, United States, 14618
United States, North Carolina
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Scranton, Pennsylvania, United States, 18503
United States, Texas
Austin, Texas, United States, 78754
Irving, Texas, United States, 75062
United States, Utah
Salt Lake City, Utah, United States, 84106
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, 071000
Beijing, China, 100083
Beijing, China, 100088
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
Napoli, Campania, Italy, 80131
Brescia, Lombardia, Italy, 25123
Milano, Lombardia, Italy, 20121
Milano, Lombardia, Italy, 20122
Torino, Piemonte, Italy, 10126
Bari, Puglia, Italy, 70124
Pisa, Toscana, Italy, 56124
Pisa, Toscana, Italy, 56126
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, 162-8666
Tokyo, Japan, 187-8551
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01235559     History of Changes
Other Study ID Numbers: WN25305
2010-020718-26
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders