Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)

NCT00988728 | Withdrawn Phase 2 DMC

• 1 other identifier: P06079
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

  4 weeks (Day 28)

Secondary Outcomes (1)

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

  4 weeks

Study Arms (3)

SCH 900435

EXPERIMENTAL

SCH 900435 (Org 25935): a Glycine Uptake Inhibitor

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

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Olanzapine

ACTIVE COMPARATOR

Drug: Placebo; Drug: Olanzapine

Interventions

SCH 900435 (Org 25935) DRUG

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).

SCH 900435

Placebo DRUG

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.

Olanzapine; Placebo; SCH 900435

Olanzapine DRUG

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).

Also known as: Zyprexa®

Olanzapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

N-methyl-N-(6-methoxy-1-phenyl-1,2,3,4-tetrahydronaphthalen-2-ylmethyl)aminomethylcarboxylic acid; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 17, 2015

Record last verified: 2015-12