Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Forest Investigative Site 001, Glendale, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Heart rate-corrected QT interval (QTc)

Time frame: 35 days of double-blind treatment, up to 56 days total.

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.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 20, 2011
Registry last updated: Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed