Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder

NCT00181922 | Completed Phase 4

• 1 other identifier: 2002-p-000183
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to compare the safety and effectiveness of Ziprasidone in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.

Conditions

Bipolar Disorder; Mania

Keywords

bipolar disorder; children; ziprasidone; mania

Outcome Measures

Primary Outcomes (3)

• reduction in symptoms assessed by

• Clinical Global Improvement scale (Severity, Improvement and Efficacy Index)

• Young Mania Rating Scale

Interventions

ziprasidone (Geodon) DRUG

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females age 6 to 18 years of age
• Parent or legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
• Patients and their legal representative must be considered reliable.
• Each patient and his/her authorized legal representative must understand the nature of the study. The patient's authorized legal representative must sign an informed consent document.
• Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
• Patients must have an initial score on the Y-MRS total score of at least 15.
• Patient must be able to participate in mandatory blood draws.
• Patient must be able to swallow pills.

You may not qualify if:

• Patients with chronic medical illness, DSM-IV substance dependence within the past 6 months, pregnant or nursing females, and those at serious risk of suicide will be excluded from the study
• investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
• Serious unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
• Known history of QT prolongation (ie. Congenital long QT syndrome), cardiac arrhythmia, recent myocardial infarction, or heart failure
• Concurrent medications known to prolong the QT interval including: antiarrhythmics (quinidine), antimicrobials and antimalarials (erythromycin, clarithromycin, ketoconazole, sparfloxacin, moxifloxacin, levofloxacin, gatifloxacin, chloroquine) and antihistamines (diphenhydramine, hydroxyzine).
• Known hypokalemia or hypomagnesemia
• Uncorrected hypothyroidism or hyperthyroidism
• History of severe allergies or multiple adverse drug reactions
• Non-febrile seizures without a clear and resolved etiology
• Leukopenia or history of leucopenia without a clear and resolved etiology
• DSM-IV substance (except nicotine or caffeine) dependence within the past 6 months
• Judged clinically to be at serious suicidal risk
• Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol
• History of intolerance of Ziprasidone as determined by the principal investigator.
• Treatment with an irreversible monoamine oxidase inhibitor within 2 weeks prior to visit 2

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Pfizer: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2002
• Study Completion: December 1, 2004
• Last Updated: October 22, 2013

Record last verified: 2013-10

Locations

US (2)