Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN) (GUEST)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00988728
First received: October 1, 2009
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: SCH 900435 (Org 25935)
Drug: Placebo
Drug: Olanzapine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score) [ Time Frame: 4 weeks (Day 28) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 Name: Zyprexa®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00988728     History of Changes
Other Study ID Numbers: P06079
Study First Received: October 1, 2009
Last Updated: December 18, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014