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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00181922
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 22, 2013
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Mania Drug: ziprasidone (Geodon) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2002
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00181922

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
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital

Responsible Party: Joseph Biederman, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT00181922     History of Changes
Other Study ID Numbers: 2002-p-000183
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: October 2013

Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:
bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents