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A Study of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (NN25307)

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ClinicalTrials.gov Identifier: NCT01235520
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : June 2, 2015
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 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: RO4917838 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 595 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 : January 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 1 Drug: RO4917838
Oral dose level 1, once a day for 52 weeks

Experimental: 2 Drug: RO4917838
Oral dose level 2, once a day for 52 weeks

Placebo Comparator: 3 Drug: Placebo
Oral doses, 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): NCT01235520


  Show 122 Study Locations
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: NCT01235520     History of Changes
Other Study ID Numbers: NN25307
2010-020696-23
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: June 2015

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