A Study of RO4917838 in Combination With Antipsychotic Treatment in Patients With Schizophrenia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00616798
First received: February 4, 2008
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is <3 months, and the target sample size is 100-500 individual s.


Condition Intervention Phase
Schizophrenia
Drug: RO4917838
Drug: Placebo
Drug: Standard antipsychotic therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled add-on Trial of the Safety and Efficacy of RO4917838 in Outpatients on Select Atypical Antipsychotics With Prominent Negative or Disorganized Thought Symptoms

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, C-SSRS [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 323
Study Start Date: March 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3 Drug: RO4917838
60mg po daily
Drug: Standard antipsychotic therapy
As prescribed
Placebo Comparator: 4 Drug: Placebo
po daily
Drug: Standard antipsychotic therapy
As prescribed
Experimental: 1 Drug: RO4917838
10mg po daily
Drug: Standard antipsychotic therapy
As prescribed
Experimental: 2 Drug: RO4917838
30mg po daily
Drug: Standard antipsychotic therapy
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-60 years of age;
  • diagnosis of schizophrenia (based on screening tests);
  • outpatients, with no hospitalization for worsening of schizophrenia within 3 months;
  • medically and psychiatrically stable over prior 1 month and psychiatrically stable without symptom exacerbation within prior 3 months;
  • currently taking no more than 2 antipsychotic drugs.

Exclusion Criteria:

  • began a new non-medication treatment for schizophrenia or other psychiatric condition within last 3 months;
  • on >1 antidepressant, or a change in dose of antidepressant within 3 months;
  • alcohol or substance abuse or dependence within 3 months;
  • has previously received RO4917838.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616798

  Hide Study Locations
Locations
United States, California
Granada Hills, California, United States, 91344
Los Angeles, California, United States, 90033
Oceanside, California, United States, 92056
Torrance, California, United States, 90502
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Illinois
Hoffman Estates, Illinois, United States, 60169
United States, New York
Brooklyn, New York, United States, 11203
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Austin, Texas, United States, 78756
Austin, Texas, United States, 78754
De Soto, Texas, United States, 75115
Irving, Texas, United States, 75062
Austria
Wien, Austria, 1010
Wien, Austria, 1090
Brazil
Curitiba, Brazil, 80520-000
Pelotas, Brazil, 96030-002
Rio de Janeiro, Brazil, 21020-130
Salvador, Brazil, 40301-500
Sao Paulo, Brazil, 05403-010
Sao Paulo, Brazil, 04044-000
France
Marseille, France, 13009
Orvault, France, 44700
Toulon, France, 83056
Germany
Achim, Germany, 28832
Bochum, Germany, 44805
Freiburg, Germany, 79104
Hamburg, Germany, 20246
Nürnberg, Germany, 90402
Westerstede, Germany, 26655
Hungary
Balassagyarmat, Hungary, 2660
Budapest, Hungary, 1097
Budapest, Hungary, 1135
Budapest, Hungary, 1083
Budapest, Hungary, 1125
GYR, Hungary, 9024
Gyula, Hungary, 5700
Nyíregyháza, Hungary, 4400
Japan
Aichi, Japan, 470-1192
Chiba, Japan, 272-8516
Fukuoka, Japan, 812-8582
Fukuoka, Japan, 807-8555
Gunma, Japan, 373-0054
Kanagawa, Japan, 232-0024
Kanagawa, Japan, 236-0004
Nagasaki, Japan, 852-8501
Saga, Japan, 842-0192
Sapporo, Japan, 060-8638
Tokushima, Japan, 770-8503
Tokyo, Japan, 187-8551
Tokyo, Japan, 162-8666
Mexico
Mexico City, Mexico, 06100
Mexico City, Mexico, 1400
Mexico City, Mexico, 11560
Mexico City, Mexico, 14370
Monterrey, Mexico, 64710
Poland
Bydgoszcz, Poland, 85-096
Kielce, Poland, 25-317
Skorzewo, Poland, 60-165
Torun, Poland, 87-100
Tuszyn, Poland, 95-080
Zuromin, Poland, 09-300
Russian Federation
Kazan, Russian Federation, 420012
Lipetsk, Russian Federation, 399313
Moscow, Russian Federation, 115522
Moscow, Russian Federation, 123367
Moscow, Russian Federation, 117152
Nizhny Novgorod, Russian Federation, 603155
St Petersbourg, Russian Federation, 190005
St Petersburg, Russian Federation, 193019
St Petersburg, Russian Federation, 192019
St. Petersburg, Russian Federation, 193167
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00616798     History of Changes
Other Study ID Numbers: NN20372
Study First Received: February 4, 2008
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 20, 2014