N/A
N=7
Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
Bipolar Disorder · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00338806 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: K SADS-Present Version (KSADS-P) — 0; 2; 1; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interpersonal psychotherapy for prevention with adolescents (Behavioral); Educational clinical monitoring (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY K SADS-Present Version (KSADS-P) |
0; 1 | — |
| PRIMARY K SADS-Present Version (KSADS-P) |
0; 1 | — |
| PRIMARY K SADS-Present Version (KSADS-P) |
0; 1 | — |
| PRIMARY K SADS-Present Version (KSADS-P) |
0; 1 | — |
| PRIMARY Children's Depression Rating Scale-Revised (CDRS-R) |
25 | — |
| PRIMARY Children's Depression Rating Scale-Revised (CDRS-R) |
25 | — |
| PRIMARY Children's Depression Rating Scale-Revised (CDRS-R) |
25 | — |
| PRIMARY Children's Depression Rating Scale-Revised (CDRS-R) |
25 | — |
| PRIMARY Children's Global Assessment Scale (C-GAS) |
79 | — |
| PRIMARY Children's Global Assessment Scale (C-GAS) |
79 | — |
| PRIMARY Children's Global Assessment Scale (C-GAS) |
79 | — |
| PRIMARY Children's Global Assessment Scale (C-GAS) |
79 | — |
| PRIMARY Young Mania Rating Scale (YMRS) |
3 | — |
| PRIMARY Young Mania Rating Scale (YMRS) |
3 | — |
| PRIMARY Young Mania Rating Scale (YMRS) |
3 | — |
| PRIMARY Young Mania Rating Scale (YMRS) |
3 | — |
| SECONDARY Attitudes Toward Treatment Questionnaire |
6.50; 7.20 | — |
| SECONDARY Emotion Regulation Questionnaire |
— | — |
| SECONDARY Emotion Regulation Questionnaire |
— | — |
| SECONDARY Emotion Regulation Questionnaire |
— | — |
| SECONDARY Family Assessment Device |
2.3; 2.7 | — |
| SECONDARY Family History Screen |
2; 4; 2; 3; 1; 2 | — |
| SECONDARY Mood Disorder Questionnaire |
2; 4 | — |
| SECONDARY Patient Health Questionnaire |
12; 14.5 | — |
| SECONDARY Social Adjustment Scale - Self Report for Adolescents |
— | — |
| SECONDARY Social Adjustment Scale - Self Report for Adolescents |
— | — |
| SECONDARY Social Rhythm Metric Short Form |
— | — |
| SECONDARY Treatment Credibility Scale |
4; 3.75 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00338806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.