Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Part of paid clinical trials in Glendale, California.

Sponsor
Forest Laboratories
Study ID
NCT01376076
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.

Key Dates

Start date
Jun 30, 2011
Status verified
Feb 2012
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
129 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine
  • Placebo Comparator: 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
  • Placebo Comparator: 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

Primary Outcome Measure

Heart rate-corrected QT interval (QTc) [ Time Frame: 35 days of double-blind treatment, up to 56 days total. ]

Locations (4)

FacilityCityStateZIPSite coordinators
Forest Investigative Site 001GlendaleCalifornia91206-
Forest Investigative Site 004Long BeachCalifornia90806-
Forest Investigative Site 002WillingboroNew Jersey08046-
Forest Investigative Site 003HoustonTexas77008-

Find similar trials in Glendale, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Forest Investigative· Glendale, CAForest Investigative· Long Beach, CAForest Investigative· Willingboro, NJForest Investigative· Houston, TX

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