Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN) (GUEST)

Merck Sharp & Dohme (MSD)

Status and phase: Withdrawn; Phase 2

Conditions: Schizophrenia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00988728

P06079

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

SCH 900435

Experimental group

Description:

SCH 900435 (Org 25935): a Glycine Uptake Inhibitor

Treatment:

Drug: Placebo

Drug: SCH 900435 (Org 25935)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Olanzapine

Active Comparator group

Treatment:

Drug: Placebo

Drug: Olanzapine