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

NCT ID: NCT00616798

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-02-28

Brief Summary

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

3

Group Type: EXPERIMENTAL

RO4917838

Intervention Type: DRUG

60mg po daily

Standard antipsychotic therapy

Intervention Type: DRUG

As prescribed

4

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

po daily

Standard antipsychotic therapy

Intervention Type: DRUG

As prescribed

1

Group Type: EXPERIMENTAL

RO4917838

Intervention Type: DRUG

10mg po daily

Standard antipsychotic therapy

Intervention Type: DRUG

As prescribed

2

Group Type: EXPERIMENTAL

RO4917838

Intervention Type: DRUG

30mg po daily

Standard antipsychotic therapy

Intervention Type: DRUG

As prescribed

Interventions

RO4917838

10mg po daily

Intervention Type: DRUG

RO4917838

30mg po daily

Intervention Type: DRUG

RO4917838

60mg po daily

Intervention Type: DRUG

Placebo

po daily

Intervention Type: DRUG

Standard antipsychotic therapy

As prescribed

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Granada Hills, California, United States

Los Angeles, California, United States

Oceanside, California, United States

Torrance, California, United States

Atlanta, Georgia, United States

Hoffman Estates, Illinois, United States

Brooklyn, New York, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Austin, Texas, United States

Austin, Texas, United States

DeSoto, Texas, United States

Irving, Texas, United States

Vienna, , Austria

Vienna, , Austria

Curitiba, , Brazil

Pelotas, , Brazil

Rio de Janeiro, , Brazil

Salvador, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

Marseille, , France

Orvault, , France

Toulon, , France

Achim, , Germany

Bochum, , Germany

Freiburg im Breisgau, , Germany

Hamburg, , Germany

Nuremberg, , Germany

Westerstede, , Germany

Balassagyarmat, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

GYR, , Hungary

Gyula, , Hungary

Nyíregyháza, , Hungary

Aichi, , Japan

Chiba, , Japan

Fukuoka, , Japan

Fukuoka, , Japan

Gunma, , Japan

Kanagawa, , Japan

Kanagawa, , Japan

Nagasaki, , Japan

Saga, , Japan

Sapporo, , Japan

Tokushima, , Japan

Tokyo, , Japan

Tokyo, , Japan

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Monterrey, , Mexico

Bydgoszcz, , Poland

Kielce, , Poland

Skorzewo, , Poland

Torun, , Poland

Tuszyn, , Poland

Żuromin, , Poland

Kazan', , Russia

Lipetsk, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Countries

United States; Austria; Brazil; France; Germany; Hungary; Japan; Mexico; Poland; Russia

References

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.

Reference Type: DERIVED

PMID: 24696094 (View on PubMed)

Other Identifiers

NN20372

Identifier Type: -

Identifier Source: org_study_id