Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
NCT ID: NCT01376076
Last Updated: 2012-02-08
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
129 participants
INTERVENTIONAL
2011-06-30
2012-02-29
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
TRIPLE
Study Groups
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1
Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine
Cariprazine
Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally.
2A
Double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35
Risperidone/Moxifloxacin
Patients randomized to Group 2A will receive double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35.
2B
Double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35
Risperidone/Moxifloxacin
Patients randomized to Group 2B will receive double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35.
Interventions
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Cariprazine
Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally.
Risperidone/Moxifloxacin
Patients randomized to Group 2A will receive double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35.
Risperidone/Moxifloxacin
Patients randomized to Group 2B will receive double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35.
Eligibility Criteria
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Inclusion Criteria
* Symptoms of schizophrenia or schizoaffective disorder first appearing a minimum of 1 year before screening
* Negative pregnancy test
* Normal physical examination results, vital signs, and clinical lab test results
Exclusion Criteria
* Smoking more than 20 cigarettes a day
* History or presence of cardiovascular disorder
* Pregnant/breast-feeding and/or planning to become pregnant/breast-feed
* Imminent risk of injuring self or others or causing significant property damage
18 Years
50 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Suneeta Ahuja, PhD
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site 001
Glendale, California, United States
Forest Investigative Site 004
Long Beach, California, United States
Forest Investigative Site 002
Willingboro, New Jersey, United States
Forest Investigative Site 003
Houston, Texas, United States
Countries
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Other Identifiers
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RGH-MD-02
Identifier Type: -
Identifier Source: org_study_id
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