N/A
Completed N=7
Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
Source: ClinicalTrials.gov NCT00338806 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: K SADS-Present Version (KSADS-P) — 0; 2; 1; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY K SADS-Present Version (KSADS-P) |
0; 1 | — |
| PRIMARY Children's Depression Rating Scale-Revised (CDRS-R) |
25 | — |
| PRIMARY Children's Global Assessment Scale (C-GAS) |
79 | — |
| PRIMARY Young Mania Rating Scale (YMRS) |
3 | — |
| SECONDARY Attitudes Toward Treatment Questionnaire |
6.50; 7.20 | — |
| 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 Rhythm Metric Short Form |
— | — |
| SECONDARY Treatment Credibility Scale |
4; 3.75 | — |
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. Informational only — not medical advice.