Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Evaluation of the Effects of Sequential Multiple-Dose Regimens of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376076
• Other study ID #: RGH-MD-02
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2011
• Last updated: February 7, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Men or women, age 18 to 50, inclusive

• 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:

• Axis II disorder severe enough to interfere with the study

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Forest Investigative Site 001	Glendale	California
United States	Forest Investigative Site 003	Houston	Texas
United States	Forest Investigative Site 004	Long Beach	California
United States	Forest Investigative Site 002	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate-corrected QT interval (QTc)	The effects of a therapeutic dosage (9 mg/day) and a supratherapeutic dosage (18 mg/day) of cariprazine on cardiac repolarization as determined by heart-rate-corrected QT intervals will be assessed on Day 20 and Day 34, respectively. The assay sensitivity of moxifloxacin 400 mg/day will be assessed on Day 6 and Day 35.	35 days of double-blind treatment, up to 56 days total.	Yes