Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)
NCT ID: NCT00988728
Last Updated: 2015-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2011-02-28
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SCH 900435
SCH 900435 (Org 25935): a Glycine Uptake Inhibitor
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).
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
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.
Olanzapine
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.
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).
Interventions
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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).
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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P06079
Identifier Type: -
Identifier Source: org_study_id