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Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: SCH 900435 (Org 25935) (Drug); Placebo (Drug); Olanzapine (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score)

Secondary outcome: Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Additional Information

Starting date: February 2011
Last updated: December 15, 2014

Page last updated: August 23, 2015

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