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Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN) (GUEST)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Withdrawn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
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

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

    First Posted
    October 1, 2009
    Last Updated
    December 16, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    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    Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)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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