Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN) (GUEST)
Primary Purpose
Schizophrenia
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCH 900435 (Org 25935)
Placebo
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
SCH 900435
Placebo
Olanzapine
Arm Description
SCH 900435 (Org 25935): a Glycine Uptake Inhibitor
Outcomes
Primary Outcome Measures
The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score)
Secondary Outcome Measures
Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine
Full Information
NCT ID
NCT00988728
First Posted
October 1, 2009
Last Updated
December 16, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00988728
Brief Title
Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)
Acronym
GUEST
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 Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCH 900435
Arm Type
Experimental
Arm Description
SCH 900435 (Org 25935): a Glycine Uptake Inhibitor
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Olanzapine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SCH 900435 (Org 25935)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa®
Intervention Description
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).
Primary Outcome Measure Information:
Title
The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score)
Time Frame
4 weeks (Day 28)
Secondary Outcome Measure Information:
Title
Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
12. IPD Sharing Statement
Learn more about this trial
Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)
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