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

NCT00338806 | Completed Results DMC

• 2 other identifiers: #5067K23MH071530
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder; Depression

Keywords

Prevention; Mood Disorders; Unipolar Depression

Outcome Measures

Primary Outcomes (16)

• K SADS-Present Version (KSADS-P)

  A semi-structured interview designed to assess present episode of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

  12 weeks

• K SADS-Present Version (KSADS-P)

  A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

  6 months

• K SADS-Present Version (KSADS-P)

  A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

  12 months

• K SADS-Present Version (KSADS-P)

  A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

  18 months

• Children's Depression Rating Scale-Revised (CDRS-R)

  CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores \> 41 indicate mild-moderate depression.

  Week 12

• Children's Depression Rating Scale-Revised (CDRS-R)

  CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores \> 41 indicate mild-moderate depression.

  6 months

• Children's Depression Rating Scale-Revised (CDRS-R)

  CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores \> 41 indicate mild-moderate depression.

  12 months

• Children's Depression Rating Scale-Revised (CDRS-R)

  CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores \> 41 indicate mild-moderate depression.

  18 months

• Children's Global Assessment Scale (C-GAS)

  C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

  Week 12

• Children's Global Assessment Scale (C-GAS)

  C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

  6 months

• Children's Global Assessment Scale (C-GAS)

  C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

  12 months

• Children's Global Assessment Scale (C-GAS)

  C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

  18 months

• Young Mania Rating Scale (YMRS)

  An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

  Week 12

• Young Mania Rating Scale (YMRS)

  An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

  6 months

• Young Mania Rating Scale (YMRS)

  An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

  12 months

• Young Mania Rating Scale (YMRS)

  An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

  18 months

Secondary Outcomes (12)

• Attitudes Toward Treatment Questionnaire

  Measured at Week 12

• Emotion Regulation Questionnaire

  Measured at Week 12

• Emotion Regulation Questionnaire

  6 months

• Emotion Regulation Questionnaire

  12 months and 18 months

• Family Assessment Device

  Measured at Week 12

Study Arms (2)

Interpersonal Psychotherapy-Prevention

EXPERIMENTAL

Participants will receive interpersonal psychotherapy for prevention with adolescents

Behavioral: Interpersonal psychotherapy for prevention with adolescents

Educational and Clinical Monitoring

ACTIVE COMPARATOR

Participants will receive educational clinical monitoring

Behavioral: Educational clinical monitoring

Interventions

Interpersonal psychotherapy for prevention with adolescents BEHAVIORAL

Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.

Also known as: IPT-PA

Interpersonal Psychotherapy-Prevention

Educational clinical monitoring BEHAVIORAL

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.

Also known as: ECM

Educational and Clinical Monitoring

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of BD I or II
• Currently in partial or full remission from a depressive or manic episode
• Under active clinical care
• 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

You may not qualify if:

• History of psychosis within 1 month of study entry
• At risk for suicide within 1 month of study entry
• 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)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression; Mood Disorders; Depressive Disorder

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Limitations include a very small sample size due to recruitment difficulty. In addition, participation with follow-up evaluations was poor.

Results Point of Contact

• Title: Dr. Helen Verdeli
• Organization: NYSPInstitute

verdelih@nyspi.columbia.edu

212 543 5262

Study Officials

• Helen Verdeli, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2006
• First Posted: June 20, 2006
• Study Start: November 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 15, 2017
• Results First Posted: August 15, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)