Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder

Depression Clinical Trial

Official title:

Prevention for Symptomatic Offspring of Bipolar Parents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00338806
• Other study ID #: K23MH071530
• Secondary ID: DDTR BK-TKAR
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 16, 2006
• Last updated: March 25, 2009
• Start date: November 2006
• Est. completion date: November 2009

Study information

• Verified date: March 2009
• Source: National Institute of Mental Health (NIMH)
• Contact: Helen Verdeli, PhD
• Phone: 212-543-5262
• Email: verdelih[@]childpsych.columbia.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Bipolar Disorder (BD) is a serious medical illness that causes drastic shifts in a person's mood, energy, and ability to function. BD symptoms alternate from increased energy, restlessness, and overly good mood to a lasting sad, anxious, or empty mood and feelings of hopelessness or pessimism. Research suggests that children of parents with BD are at risk for developing mood disorders because of predisposing genetic factors and stressful life events, many of which may be related to their parents' unstable clinical state. Adolescent children of parents with BD must deal simultaneously with the difficult task of negotiating their own developmental transitions, as well as living with a parent with BD. It may be possible to detect symptoms of BD or other mood disorders early in adolescence and prevent the disorder from further interfering with someone's life. This study will develop and refine strategies for early detection and primary prevention of mood disorders and associated impairment in adolescent children of parents with BD.

Participants in this single-blind study will be randomly assigned to receive either interpersonal psychotherapy with adolescents (IPT-PA) or a control intervention, educational clinical monitoring (ECM), for 12 weeks. Participants assigned to IPT-PA will attend twelve sessions. The first four sessions will last 90 minutes each, and will include both family psychoeducation and individual psychotherapy with the adolescent. The remaining sessions will be 45 minutes each, and will include only individual psychotherapy with the adolescent. Participants assigned to ECM will each be assigned to a therapist. During the initial two sessions, which will take place over 2 consecutive weeks, the therapist will focus on mood disorder psychoeducation and participants will receive related written educational material. Participants will then meet with their therapists monthly for 30-minute sessions. Symptoms and functioning will be assessed, but no assistance on building interpersonal skills will be provided. A participant may request a second session each month, but if more than two monthly sessions are required, the participant will be referred for therapy. Mood episodes and symptoms, symptom severity, and functioning will be assessed for all participants at Weeks 6 and 12 and Months 6, 12, and 18 post-treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression

Intervention

Behavioral:
• Interpersonal psychotherapy for prevention with adolescents
Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.
• Educational clinical monitoring
Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	K SADS-Present and Lifetime version (KSADS-PL)		Measured at Week 12 and Months 6, 12, and 18 post-treatment	Yes
Primary	Children's Depression Rating Scale-Revised (CDRS-R)		Measured at Week 12 and Months 6, 12, and 18 post-treatment	Yes
Primary	Young Mania Rating Scale (YMRS)		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No
Primary	Children's Global Assessment Scale (C-GAS)		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No
Secondary	Attitudes Toward Treatment Questionnaire		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No
Secondary	Emotion Regulation Checklist		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No
Secondary	Family Assessment Device		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No
Secondary	Family history screen		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No
Secondary	Mood Disorder Questionnaire		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No
Secondary	Patient Health Questionnaire		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No
Secondary	Social Adjustment Scale - Self Report		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No
Secondary	Social Rhythm Metric Short Form		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No
Secondary	Treatment Credibility Scale		Measured at Week 12 and Months 6, 12, and 18 post-treatment	No