Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN) (GUEST)

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.

Study Overview

• Status: Withdrawn
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SCH 900435 (Org 25935); Drug: Placebo; Drug: Olanzapine

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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.
Active Comparator: Olanzapine	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).; Other Names: Zyprexa®
Experimental: SCH 900435; SCH 900435 (Org 25935): a Glycine Uptake Inhibitor	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: October 1, 2009
• First Submitted That Met QC Criteria: October 1, 2009
• First Posted (Estimate): October 2, 2009

Study Record Updates

• Last Update Posted (Estimate): December 17, 2015
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: P06079