View Clinical Trial (Medical Research Study)
Prevention for Symptomatic Offspring of Bipolar Parents
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10032 |
| Conditions: |
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Bipolar Disorder - Depression |
| Purpose: |
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This study will develop strategies for early detection and prevention of mood disorders and
associated impairment in adolescent children of parents with bipolar disorder.
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| Study Summary: |
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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 good mood to a lasting sad, anxious, or empty mood and feelings of
hopelessness or pessimism. Research suggests that children of parents with BD are at risk
for developing mood disorders because of predisposing genetic factors and stressful life
events, many of which may be related to their parents' unstable clinical state. Adolescent
children of parents with BD must deal simultaneously with the difficult task of negotiating
their own developmental transitions, as well as living with a parent with BD. It may be
possible to detect symptoms of BD or other mood disorders early in adolescence and prevent
the disorder from further interfering with someone's life. This study will develop and
refine strategies for early detection and primary prevention of mood disorders and
associated impairment in adolescent children of parents with BD.
Participants in this single-blind study will be randomly assigned to receive either
interpersonal psychotherapy with adolescents (IPT-PA) or a control intervention, educational
clinical monitoring (ECM), for 12 weeks. Participants assigned to IPT-PA will attend twelve
sessions. The first four sessions will last 90 minutes each, and will include both family
psychoeducation and individual psychotherapy with the adolescent. The remaining sessions
will be 45 minutes each, and will include only individual psychotherapy with the adolescent.
Participants assigned to ECM will each be assigned to a therapist. During the initial two
sessions, which will take place over 2 consecutive weeks, the therapist will focus on mood
disorder psychoeducation and participants will receive related written educational material.
Participants will then meet with their therapists monthly for 30-minute sessions. Symptoms
and functioning will be assessed, but no assistance on building interpersonal skills will be
provided. A participant may request a second session each month, but if more than two
monthly sessions are required, the participant will be referred for therapy. Mood episodes
and symptoms, symptom severity, and functioning will be assessed for all participants at
Weeks 6 and 12 and Months 6, 12, and 18 post-treatment.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00338806 |
| Primary Contact: |
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Principal Investigator
Helen Verdeli, PhD
New York State Psychiatric Institute
Helen Verdeli, PhD
Phone: 212-543-5262
Email: verdelih@childpsych.columbia.edu
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| Backup Contact: |
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Email: ks446@columbia.edu
Karen A. Shoum, MA
Phone: 212-543-5262
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| Location Contact: |
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New York, New York 10032
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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