Early Intervention for Youth at Risk for Bipolar Disorder

Completed · Not applicable

Conditions studied: Bipolar Disorder, Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01483391

Run by

University of California, Los Angeles

People needed

150

Starts

2011-10-06

Expected to finish

2020-09-15

Last updated by the study team

2021-10-04

Who can join

Age: 9 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine — Los Angeles, California, United States
• Stanford University School of Medicine, Lucile Packard Children's Hospital — Stanford, California, United States
• University of Colorado, Boulder — Boulder, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.