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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616798

Enrollment

323

Registered

2008-02-15

Start date

2008-03-31

Completion date

2010-02-28

Last updated

2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

DRUGRO4917838

10mg po daily

DRUGPlacebo

po daily

DRUGStandard antipsychotic therapy

As prescribed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026