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Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01376076
First received: June 16, 2011
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Cariprazine
Drug: Risperidone/Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Sequential Multiple-Dose Regimens of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Heart rate-corrected QT interval (QTc) [ Time Frame: 35 days of double-blind treatment, up to 56 days total. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 129
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine
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.
Placebo Comparator: 2A
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
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.
Placebo Comparator: 2B
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376076

Locations
United States, California
Forest Investigative Site 001
Glendale, California, United States, 91206
Forest Investigative Site 004
Long Beach, California, United States, 90806
United States, New Jersey
Forest Investigative Site 002
Willingboro, New Jersey, United States, 08046
United States, Texas
Forest Investigative Site 003
Houston, Texas, United States, 77008
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Suneeta Ahuja, PhD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01376076     History of Changes
Other Study ID Numbers: RGH-MD-02
Study First Received: June 16, 2011
Last Updated: February 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
schizophrenia
QTc
cardiac repolarization

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Risperidone
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Dopamine Agents
Dopamine Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Reproductive Control Agents
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 19, 2014