Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
This study has been completed.
Sponsor:
Forest Laboratories
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Moxifloxacin Norgestimate, ethinyl estradiol drug combination Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents Anti-Infective Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 16, 2013