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Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cariprazine
Risperidone/Moxifloxacin
Risperidone/Moxifloxacin
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, QTc, cardiac repolarization

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Forest Investigative Site 001
  • Forest Investigative Site 004
  • Forest Investigative Site 002
  • Forest Investigative Site 003

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

1

2A

2B

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2011
Last Updated
February 7, 2012
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01376076
Brief Title
Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
Official Title
Evaluation of the Effects of Sequential Multiple-Dose Regimens of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, QTc, cardiac repolarization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine
Arm Title
2A
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
2B
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Intervention Description
Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally.
Intervention Type
Drug
Intervention Name(s)
Risperidone/Moxifloxacin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Risperidone/Moxifloxacin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart rate-corrected QT interval (QTc)
Description
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.
Time Frame
35 days of double-blind treatment, up to 56 days total.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suneeta Ahuja, PhD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 001
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Forest Investigative Site 004
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Forest Investigative Site 002
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Forest Investigative Site 003
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States

12. IPD Sharing Statement

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Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

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