NCT01376076

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

8 months

First QC Date

June 16, 2011

Last Update Submit

February 7, 2012

Conditions

Schizophrenia

Keywords

schizophreniaQTccardiac repolarization

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (3)

1

EXPERIMENTAL

Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine

Drug: Cariprazine

2A

PLACEBO COMPARATOR

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

Drug: Risperidone/Moxifloxacin

2B

PLACEBO COMPARATOR

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

Drug: Risperidone/Moxifloxacin

Interventions

CariprazineDRUG

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

1
Risperidone/MoxifloxacinDRUG

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.

2A

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Forest Investigative Site 001

Glendale, California, 91206, United States

Location

Forest Investigative Site 004

Long Beach, California, 90806, United States

Location

Forest Investigative Site 002

Willingboro, New Jersey, 08046, United States

Location

Forest Investigative Site 003

Houston, Texas, 77008, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

cariprazineRisperidoneMoxifloxacin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Suneeta Ahuja, PhD

    Forest Laboratories

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 8, 2012

Record last verified: 2012-02

Locations

US(4)