Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Parallel-Group, Double-blind, Fixed-Dose, 28-Day Trial to Assess the Efficacy and Safety of SCH 900435 Compared With Placebo, Using Olanzapine as an Active Control in Subjects With an Acute Exacerbation of Schizophrenia (GUEST - Glycine Uptake Inhibitor Efficacy and Safety Trial, Phase 2, Protocol No. P06079)

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: SCH 900435 (Org 25935)
* Drug: Placebo
* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCH 900435<br>SCH 900435 (Org 25935): a Glycine Uptake Inhibitor | Drug: SCH 900435 (Org 25935)<br>* Oral tablets, containing 8 mg of active substance, two tablets (i.e. 16 mg) to be taken twice daily in the morning after breakfast and in the evening after dinner during 4 weeks. Because of double-dummy design, subjects will be administered two tablets in the morning, and two tablets plus one capsule in the evening (in total 4 tablets with SCH 900435 plus 1 capsule with placebo per day).<br>Drug: Placebo<br>* Oral capsules and tablets containing excipients only. Because of the double-dummy design, subjects will be administered one capsule in the evening, plus two tablets in the morning after breakfast and two tablets after dinner.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral capsules and tablets containing excipients only. Because of the double-dummy design, subjects will be administered one capsule in the evening, plus two tablets in the morning after breakfast and two tablets after dinner.<br>|
| Active Comparator: Olanzapine<br> | Drug: Placebo<br>* Oral capsules and tablets containing excipients only. Because of the double-dummy design, subjects will be administered one capsule in the evening, plus two tablets in the morning after breakfast and two tablets after dinner.<br>Drug: Olanzapine<br>* Oral capsules containing 15 mg of active substance, one capsule to be taken once daily after dinner for four weeks. Because of double-dummy design, subjects will be administered two tablets in the morning, and two tablets plus one capsule in the evening (in total 4 tablets with placebo plus 1 capsule with olanzapine per day).<br>* Other names: Zyprexa®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score) |  | 4 weeks (Day 28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine |  | 4 weeks |