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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181922
First received: September 13, 2005
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Mania
Drug: ziprasidone (Geodon)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Study of Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • reduction in symptoms assessed by
  • Clinical Global Improvement scale (Severity, Improvement and Efficacy Index)
  • Young Mania Rating Scale

Estimated Enrollment: 20
Study Start Date: March 2002
Study Completion Date: December 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181922

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Pfizer
Investigators
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Joseph Biederman, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181922     History of Changes
Other Study ID Numbers: 2002-p-000183
Study First Received: September 13, 2005
Last Updated: October 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
bipolar disorder
children
ziprasidone
mania

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014