Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)
Phase 2
Withdrawn
- Conditions
- Schizophrenia
- Interventions
- Registration Number
- NCT00988728
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to assess whether SCH 900435 (Org 25935) 16 mg twice daily is more effective than placebo in the treatment of patients with schizophrenia, using olanzapine 15 mg once daily as active control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-
Subjects eligible to participate:
- present a substantial and recent exacerbation of schizophrenia
- have responded positively to treatment with an antipsychotic other than clozapine in the past
- are without adequate treatment for their symptoms, or willing and capable to stop concurrent medication, which appears inadequate to treat their condition, prior to participation
Exclusion Criteria
- Schizoaffective disorder;
- single episode of schizophrenia in partial remission
- concomitant use of antidepressants, mood-stabilizers (including anticonvulsants) or long-acting sedatives
- substance abuse or dependence (excluding nicotine and caffeine)
- uncompensated medical illness (including clinically relevant eye disorder)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SCH 900435 Placebo SCH 900435 (Org 25935): a Glycine Uptake Inhibitor Placebo Placebo - SCH 900435 SCH 900435 (Org 25935) SCH 900435 (Org 25935): a Glycine Uptake Inhibitor Olanzapine Placebo - Olanzapine Olanzapine -
- Primary Outcome Measures
Name Time Method The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score) 4 weeks (Day 28)
- Secondary Outcome Measures
Name Time Method Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine 4 weeks