Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
- Conditions
- Bipolar Disorder
- Interventions
- Drug: placebo oral capsules
- Registration Number
- NCT02075047
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The purpose of this study is to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 171
- DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years.
- Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo oral capsules - ziprasidone ziprasidone oral capsules -
- Primary Outcome Measures
Name Time Method Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4 Baseline, Week 4 YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 Baseline, Week 1, 2, 3, 4 CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill), higher scores indicated more severity of illness.
Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3 Baseline, Week 1, 2, 3 YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania.
Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4 Baseline, Week 1, 2, 3, 4 CGI-I: 7-point clinician rated scale which rates the participant's improvement or worsening from baseline, ranging from 1 (very much improved) to 7 (very much worse), higher scores indicate less improvement.
Trial Locations
- Locations (50)
Harmonex Neuroscience Research, Inc.
🇺🇸Dothan, Alabama, United States
Woodland International Research Group Inc.
🇺🇸Little Rock, Arkansas, United States
Woodland International Research Group, LLC
🇺🇸Little Rock, Arkansas, United States
California Pharmaceutical Research Institute
🇺🇸Anaheim, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Asclepes Research Centers
🇺🇸Panorama City, California, United States
University of California Davis Medical Center MIND Institute
🇺🇸Sacramento, California, United States
Elite Clinical Trials, Incorporated
🇺🇸Wildomar, California, United States
Children's National Health System
🇺🇸Washington, District of Columbia, United States
Da Vinci Research Institute Inc
🇺🇸Boca Raton, Florida, United States
Scroll for more (40 remaining)Harmonex Neuroscience Research, Inc.🇺🇸Dothan, Alabama, United States