MedDataX Logo

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

NCT ID: NCT00181922

Last Updated: 2013-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2004-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Initial clinical evidence suggests that atypical neuroleptics may play a unique therapeutic role in the management of symptoms in youth with bipolar disorder. Ziprasidone is classed as an atypical neuroleptic because of its unique pharmacological profile that includes both D2 and 5HT2 antagonistic effects. This combined dopaminergic and serotonergic activity seems to be associated not only with antipsychotic effects but also with mood stabilizing, mood elevating and anti-aggressive effects as well as a lower risk for extrapyramidal symptoms and tardive dyskinesia.

Ziprasidone in particular has been found to have a higher 5HT2A to D2 receptor affinity ratio, which suggests that the likelihood of extrapyramidal symptoms and hyperprolactinemia may be further decreased. This makes it an ideal candidate to treat mania in children, but although it is used in clinical practice, adequate data has not been collected on its safety and effectiveness. This study included 1) an 8-week acute period, during which participants were observed during weekly visits, and up to a 10-month extension period, during which participants saw a study clinician on a monthly basis, to document the response rate 2) assessment of the impact of Ziprasidone on functional capacities (quality of life, psychosocial function) and cognition, 3) careful assessment of safety and tolerability.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder Mania

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

bipolar disorder children ziprasidone mania

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ziprasidone (Geodon)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Males and females age 6 to 18 years of age
2. 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.
3. Patients and their legal representative must be considered reliable.
4. 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.
5. 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).
6. Patients must have an initial score on the Y-MRS total score of at least 15.
7. Patient must be able to participate in mandatory blood draws.
8. Patient must be able to swallow pills.

Exclusion Criteria

1. 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
2. investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
3. Serious unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
4. Known history of QT prolongation (ie. Congenital long QT syndrome), cardiac arrhythmia, recent myocardial infarction, or heart failure
5. 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).
6. Known hypokalemia or hypomagnesemia
7. Uncorrected hypothyroidism or hyperthyroidism
8. History of severe allergies or multiple adverse drug reactions
9. Non-febrile seizures without a clear and resolved etiology
10. Leukopenia or history of leucopenia without a clear and resolved etiology
11. DSM-IV substance (except nicotine or caffeine) dependence within the past 6 months
12. Judged clinically to be at serious suicidal risk
13. Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol
14. History of intolerance of Ziprasidone as determined by the principal investigator.
15. Treatment with an irreversible monoamine oxidase inhibitor within 2 weeks prior to visit 2
16. Current diagnosis of schizophrenia
17. For concomitant stimulant therapy used to treat ADHD, patients must have been on a stable dose of medication for 1 month prior to randomization
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joseph Biederman, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph Biederman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Cambridge, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2002-p-000183

Identifier Type: -

Identifier Source: org_study_id