Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)

Official Title: “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)”

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.

Intervention(s) in this Clinical Trial

• Drug: SCH 900435 (Org 25935)
  • 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).
• Drug: Placebo
  • 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.
• Drug: Olanzapine
  • 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).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: SCH 900435
  • SCH 900435 (Org 25935): a Glycine Uptake Inhibitor
• Placebo Comparator: Placebo
• Active Comparator: Olanzapine

Primary Measures

• The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score)
  • Time Frame: 4 weeks (Day 28)
    Safety Issue?: No

Secondary Measures

• Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine
  • Time Frame: 4 weeks
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Schering-Plough Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00988728

Study ID Number: P06079

ClinicalTrials.gov Identifier: NCT00988728

Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation