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

NCT00181922

Last updated date
Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder, Mania
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Bipolar Disorder, ManiaZiprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder
NCT00181922
  1. Boston, Massachusetts
  2. Cambridge, Massachusetts
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder
Official Title  ICMJE Open-Label Study of Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Spectrum Disorder
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Mania
Intervention  ICMJE Drug: ziprasidone (Geodon)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00181922
Other Study ID Numbers  ICMJE 2002-p-000183
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Biederman, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Joseph Biederman, MDMassachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP