Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01376076

Enrollment

129

Registered

2011-06-20

Start date

2011-06-30

Completion date

2012-02-29

Last updated

2012-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia, QTc, cardiac repolarization

Brief summary

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

Interventions

DRUGCariprazine

Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally.

DRUGRisperidone/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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Heart rate-corrected QT interval (QTc)	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026