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Completed

NCT Number: NCT00616798

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RO4917838

Drug

10mg po daily

Placebo

Drug

po daily

Standard Antipsychotic Therapy

Drug

As prescribed

Primary outcomes

  1. Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.

    Time frame: Week 8

Secondary outcomes

  1. Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.

    Time frame: Throughout study

  2. AEs, laboratory parameters, C-SSRS

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 15, 2008
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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