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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: RO4917838; Drug: RO4917838; Drug: RO4917838; Drug: Standard antipsychotic therapy

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1090
  • Wien, Austria, 1010
• 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, 1125
  • Budapest, Hungary, 1083
  • Budapest, Hungary, 1135
  • Budapest, Hungary, 1097
  • 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, 11560
  • Mexico City, Mexico, 1400
  • 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, 192019
  • St Petersburg, Russian Federation, 193019
  • St. Petersburg, Russian Federation, 193167
• 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
  • Georgia
    • Atlanta, Georgia, United States, 30308
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
  • New York
    • Brooklyn, New York, United States, 11203
  • Ohio
    • Cincinnati, Ohio, United States, 45267
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
  • Texas
    • Austin, Texas, United States, 78756
    • Austin, Texas, United States, 78754
    • De Soto, Texas, United States, 75115
    • Irving, Texas, United States, 75062

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: RO4917838; 10mg po daily; Drug: RO4917838; 30mg po daily; Drug: RO4917838; 60mg po daily; Drug: Standard antipsychotic therapy; As prescribed
Experimental: 2	Drug: RO4917838; 10mg po daily; Drug: RO4917838; 30mg po daily; Drug: RO4917838; 60mg po daily; Drug: Standard antipsychotic therapy; As prescribed
Experimental: 3	Drug: RO4917838; 10mg po daily; Drug: RO4917838; 30mg po daily; Drug: RO4917838; 60mg po daily; Drug: Standard antipsychotic therapy; As prescribed
Placebo Comparator: 4	Drug: Placebo; po daily; Drug: Standard antipsychotic therapy; As prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.	Throughout study
AEs, laboratory parameters, C-SSRS	Throughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Umbricht D, Alberati D, Martin-Facklam M, Borroni E, Youssef EA, Ostland M, Wallace TL, Knoflach F, Dorflinger E, Wettstein JG, Bausch A, Garibaldi G, Santarelli L. Effect of bitopertin, a glycine reuptake inhibitor, on negative symptoms of schizophrenia: a randomized, double-blind, proof-of-concept study. JAMA Psychiatry. 2014 Jun;71(6):637-46. doi: 10.1001/jamapsychiatry.2014.163.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: February 4, 2008
• First Submitted That Met QC Criteria: February 13, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antipsychotic Agents
• Other Study ID Numbers: NN20372