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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616798
• Other study ID #: NN20372
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2008
• Last updated: June 23, 2014
• Start date: March 2008
• Est. completion date: February 2010

Study information

• Verified date: June 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• RO4917838
10mg po daily
• RO4917838
30mg po daily
• RO4917838
60mg po daily
• Placebo
po daily
• Standard antipsychotic therapy
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  France,  Germany,  Hungary,  Japan,  Mexico,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.		Week 8	No
Secondary	Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.		Throughout study	No
Secondary	AEs, laboratory parameters, C-SSRS		Throughout study	No