Status:
COMPLETED
Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Depression
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
This study will develop strategies for early detection and prevention of mood disorders and associated impairment in adolescent children of parents with bipolar disorder.
Detailed Description
Bipolar Disorder (BD) is a serious medical illness that causes drastic shifts in a person's mood, energy, and ability to function. BD symptoms alternate from increased energy, restlessness, and overly...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Parents:
- Diagnosis of BD I or II
- Currently in partial or full remission from a depressive or manic episode
- Under active clinical care
- Inclusion Criteria for Adolescents:
- Speaks English or Spanish
- Presence of at least one current mood symptom meeting DSM-IV Criterion A and at least one depression or mania symptom meeting DSM-IV Criterion B
- Depression, irritability, anhedonia, or elated mood scored at level 2 or 3 on the KSADS-PL
- Mania symptom scored at level 2 or 3 on the KSADS-PL scale
- Score of less than 40 on the CDRS-R scale
- Score of less than 15 on the YMRS scale
- Mild-moderate functional impairment, defined as a score of greater than 61 and less than 75 on the C-GAS scale
- Exclusion Criteria for Parents:
- History of psychosis within 1 month of study entry
- At risk for suicide within 1 month of study entry
- Exclusion Criteria for Adolescents:
- Past major depressive or manic episode
- Current or past psychosis
- History of suicide attempts
- Current substance use disorder
- Use of psychotropic medications and other medications that might impact mood (e.g., steroids)
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00338806
Start Date
November 1 2006
End Date
July 1 2012
Last Update
August 15 2017
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032