Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-27 @ 9:38 AM
Study NCT ID:
NCT01235559
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C550631', 'term': '(4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 604}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2016-07-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2010-10-22', 'dispFirstSubmitQcDate': '2016-07-06', 'studyFirstSubmitQcDate': '2010-11-04', 'dispFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'Change from baseline to Week 12'}, {'measure': 'Safety (incidence of adverse events)', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'Change from baseline to Week 12'}, {'measure': 'Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale', 'timeFrame': 'Change from baseline to Week 12'}, {'measure': 'Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale', 'timeFrame': 'Change from baseline to Week 12'}, {'measure': 'Safety (incidence of adverse events)', 'timeFrame': '60 weeks'}]}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '27816567', 'type': 'DERIVED', 'citation': 'Bugarski-Kirola D, Iwata N, Sameljak S, Reid C, Blaettler T, Millar L, Marques TR, Garibaldi G, Kapur S. Efficacy and safety of adjunctive bitopertin versus placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics: results from three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies in the SearchLyte clinical trial programme. Lancet Psychiatry. 2016 Dec;3(12):1115-1128. doi: 10.1016/S2215-0366(16)30344-3. Epub 2016 Nov 2.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Diagnosis of schizophrenia\n* Clinical stability for 16 weeks (4 months) prior to randomization\n* Antipsychotic treatment stability for the past 12 weeks prior to randomization\n* With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)\n\nExclusion Criteria:\n\n* Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials\n* 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)\n* Patient has a body mass index (BMI) of \\<17 or \\>40 kg/m2, respectively)\n* Diagnosis of mental retardation or severe organic brain syndromes\n* In the investigator\'s judgment, a significant risk of suicide or violent behavior"'}, 'identificationModule': {'nctId': 'NCT01235559', 'briefTitle': 'A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'WN25305'}, 'secondaryIdInfos': [{'id': '2010-020718-26'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'bitopertin [RO4917838] 1', 'interventionNames': ['Drug: bitopertin [RO4917838] level 1']}, {'type': 'EXPERIMENTAL', 'label': 'bitopertin [RO4917838] 2', 'interventionNames': ['Drug: bitopertin [RO4917838] level 2']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral doses, once a day for 52 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'bitopertin [RO4917838] level 1', 'type': 'DRUG', 'description': 'Oral dose level 1, once a day for 52 weeks', 'armGroupLabels': ['bitopertin [RO4917838] 1']}, {'name': 'bitopertin [RO4917838] level 2', 'type': 'DRUG', 'description': 'Oral dose level 2, once a day for 52 weeks', 'armGroupLabels': ['bitopertin [RO4917838] 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92626', 'city': 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