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Early Intervention for Youth at Risk for Bipolar Disorder
Not Recruiting
Trial ID: NCT01483391
Purpose
Children or teens with mood swings or depression who have a parent with bipolar disorder are
at high risk for developing bipolar disorder themselves. This study will test a family-based
therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk
children (ages 9-17). In a randomized trial, the investigators will compare two kinds of
family-based treatment (one more and one less intensive) on the course of early mood symptoms
and social functioning among high-risk children followed for up to 4 years. The investigators
will examine the effects of family treatment on measures of neural activation using
functional magnetic resonance imaging.
Official Title
Early Intervention for Youth at Risk for Bipolar Disorder
Eligibility
Inclusion Criteria:
- For a child to be eligible:
- At least one biological parent or stepparent with whom the child or adolescent
lives must be willing to participate in family treatment
- At least one biological parent has a verifiable diagnosis of bipolar disorder I
or II
- The child must have a DSM-IV diagnosis of bipolar disorder not otherwise
specified or major depressive disorder (MDD)
- If the main diagnosis is MDD, the depressive episode must have occurred within
the past 2 years
- The child must have evidence of current significant affective symptoms, as
determined by a score greater than 11 on the Young Mania Rating Scale within the
last week or a score greater than 29 on the Child Depression Rating Scale-Revised
within the last 2 weeks
- The family must speak English, although English need not be their first language
Exclusion Criteria:
- Fully diagnosable bipolar disorder I or II
- Diagnosis of autism or pervasive developmental disorder
- Evidence of mental retardation, as defined by an intelligence quotient (IQ) less than
70
- Presence of comorbid neurologic diseases such as seizure disorder
- Substance or alcohol abuse or dependence disorders in the 4 months prior to study
recruitment
- Evidence of a life-threatening eating disorder or other medical disorder that requires
emergency medical treatment
- Currently enrolled in regular family therapy
- Evidence of current sexual or physical abuse or domestic abuse between the adult
partners
Intervention(s):
behavioral: Enhanced Care
behavioral: Family-Focused Treatment
behavioral: Enhanced Care
behavioral: Family-Focused Treatment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kiki D Chang, MD
650-725-0956