Early Assessment and Intervention for Adolescents at Risk for Bipolar Disorder

Completed · Not applicable

Conditions studied: Bipolar Disorder, Early Intervention

In brief

Bipolar disorder is a severe and chronic illness associated with significant occupational and social impairment, enormous public health costs, and high rates of suicide. The single most potent risk factor for the development of bipolar disorder is a first-degree family member with the illness; indeed, offspring of parents with bipolar disorder are a particularly high-risk group who typically display early onset and severe course of illness. Thus, early assessment and intervention for the children of parents with bipolar disorder focused on specific, measurable, and modifiable risk factors has the potential to prevent or ameliorate the progression of bipolar disorder in those at highest risk.

Key facts

Study ID

NCT03203707

Run by

University of Pittsburgh

People needed

50

Starts

2011-04-01

Expected to finish

2015-02-28

Last updated by the study team

2021-02-03

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age between 12-18 years;
• primary residence with a parent or guardian;
• English language fluency and at minimum a 3rd grade literacy level. Subjects must be able to speak and understand English because one of the study interventions, Brief IPSRT, is an experimental talk-therapy. This therapy cannot practically be translated;
• a biological parent with a diagnosis of Bipolar Disorder I, II or Not Otherwise Specified (NOS) confirmed via semi-structured diagnostic interview;
• able and willing to give informed consent/assent to participate.

You may not qualify if…

• a current or lifetime bipolar spectrum disorder diagnosis (i.e., Bipolar Disorder I, II or NOS) by the Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL);
• a primary sleep disorder diagnosis by the Structured Interview for DSM-IV Sleep Disorders;
• current unstabilized psychiatric symptoms as evidenced by a CGI-Severity of > 5 (markedly ill) and/or a C-GAS rating of < 50 (denotes serious symptoms);
• evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records,
• a prior course of IPSRT treatment
• the absence of parental participation for 18 year old potential participants (i.e. 18 year old adolescent subjects need a biological parent with a diagnosis of Bipolar Disorder I, II or Not Otherwise Specified (NOS) to particpate in the study in order for the adolescent to be able to participate) -

Where it is running

• Western Psychiatric Institute and Clinic / University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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