Treatment and Outcome of Early Onset Bipolar Disorder
2 other identifiers
interventional
40
1 country
1
Brief Summary
This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2002
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 8, 2002
CompletedFirst Posted
Study publicly available on registry
November 13, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedJanuary 22, 2014
January 1, 2014
4 years
November 8, 2002
January 21, 2014
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Have a diagnosis of Bipolar I Disorder;
- Have had aggressive and/or psychotic features (delusions, hallucinations and/or thought disorder) during the most recent manic episode;
- Is willing to be treated or is already being treated with the combination of mood stabilizer(s) (lithium or Depakote) and an atypical antipsychotic medication (Abilify, Geodon, Risperdal, Seroquel, or Zyprexa);
- Live in the NY Metropolitan area;
- Able to attend weekly to biweekly office visits
You may not qualify if:
- Medical contraindication to treatment with lithium and divalproex
- Seizure disorder
- Pregnancy
- Unwillingness to use acceptable methods of birth control if sexually active
- IQ less than 70
- Substance-induced mood disorder or mood disorder due to a general medical condition
- Prior experience with re-emergence of psychotic features or severe aggression within 6 months of antipsychotic medication discontinuation under circumstances similar to those in the study
- Potentially lethal suicide attempts or infliction of serious injury upon someone during most severe bipolar episode
- High risk for running away or truancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
The Zucker Hillside Hospital, Long Island Jewish Medical Center
Glen Oaks, New York, 11004, United States
Related Publications (3)
Kafantaris V, Coletti DJ, Dicker R, Padula G, Kane JM. Adjunctive antipsychotic treatment of adolescents with bipolar psychosis. J Am Acad Child Adolesc Psychiatry. 2001 Dec;40(12):1448-56. doi: 10.1097/00004583-200112000-00016.
PMID: 11765291BACKGROUNDKafantaris V. Treatment of bipolar disorder in children and adolescents. J Am Acad Child Adolesc Psychiatry. 1995 Jun;34(6):732-41. doi: 10.1097/00004583-199506000-00013.
PMID: 7608046BACKGROUNDKafantaris V, Coletti D, Dicker R, Padula G, Kane JM. Lithium treatment of acute mania in adolescents: a large open trial. J Am Acad Child Adolesc Psychiatry. 2003 Sep;42(9):1038-45. doi: 10.1097/01.CHI.0000070247.24125.24.
PMID: 12960703BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 8, 2002
First Posted
November 13, 2002
Study Start
August 1, 2002
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
January 22, 2014
Record last verified: 2014-01