Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia
NCT ID: NCT02202226
Last Updated: 2015-03-06
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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COMPLETED
PHASE1
96 participants
INTERVENTIONAL
2013-01-31
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
DOUBLE
Study Groups
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Lu AF35700 oral solution (1 mg/mL)
Planned daily doses range from 5 mg/day to 30 mg/day for 3 weeks. Weekly doses up to 75 mg/week for 3 weeks.
Lu AF35700
Matching placebo
Oral solution
Placebo
Interventions
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Lu AF35700
Placebo
Eligibility Criteria
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Inclusion Criteria
* BMI of ≤38
* Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
* Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at screening and baseline
* PANSS total score ≤80
* Score ≤4 (moderate) on the following PANSS items at screening and safety baseline: P7 (hostility), G8 (uncooperativeness)
* Willing to be hospitalised for 4 to 5 weeks after the Safety Baseline Visit
Exclusion Criteria
* The patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks
* The patient has a diagnosis or history of substance dependence (except nicotine) or substance abuse according to DSM-IV-TR® criteria ≤3 months prior to screening
* The patient smokes \>20 cigarettes per day
18 Years
60 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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PAREXEL Phase I Unit
Glendale, California, United States
Countries
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Other Identifiers
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14754A
Identifier Type: -
Identifier Source: org_study_id
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