NCT00257166CompletedPhase 3
Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country238 target enrollmentStarted: January 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4
Study Overview
Brief Summary
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 10 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years
Exclusion Criteria
- •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
Arms & Interventions
Ziprasidone oral capsules
Experimental
Intervention: Ziprasidone oral capsules (Drug)
Placebo
Placebo Comparator
Intervention: placebo oral capsules (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4
Time Frame: Baseline, Week 4
YMRS: an 11-item scale that measured the severity of manic episodes. Four items 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 ranged from 0 to 60, higher score indicated higher severity of mania.
Secondary Outcomes
- Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3(Baseline, Week 1, 2, 3)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4(Baseline, Week 1, 2, 3, 4)
- Clinical Global Impression - Improvement (CGI-I) Score(Week 1, 2, 3, 4)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Withdrawn
Phase 3
Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)Bipolar DisorderNCT01117220Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Terminated
Phase 3
Safety And Efficacy Of Ziprasidone In Adolescents With SchizophreniaSchizophreniaNCT00257192Pfizer's Upjohn has merged with Mylan to form Viatris Inc.284
Completed
Phase 4
Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)Bipolar DisorderPanic DisorderGeneralized Anxiety DisorderNCT01172652VA Palo Alto Health Care System49
Terminated
Phase 3
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I DisorderBipolar DisorderNCT02075047Pfizer's Upjohn has merged with Mylan to form Viatris Inc.171
Completed
Phase 2
A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive DisorderMajor Depressive DisorderNCT00555997Massachusetts General Hospital120