Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN) (GUEST)
This study has been withdrawn prior to enrollment.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00988728
First received: October 1, 2009
Last updated: September 28, 2010
Last verified: September 2010
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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 Schering-Plough:
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 ]
| Estimated Enrollment: | 200 |
| 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). 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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00988728 History of Changes |
| Other Study ID Numbers: | P06079 |
| Study First Received: | October 1, 2009 |
| Last Updated: | September 28, 2010 |
| Health Authority: | Russia: Ministry of Health of the Russian Federation |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 22, 2013