NCT02003690

Brief Summary

Of all psychiatric diagnoses, bipolar disorder imparts the greatest risk for completed suicide in adolescence, and is further associated with poor psychosocial functioning, substance abuse and legal difficulties, and exorbitant healthcare costs exceeding those for other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of pediatric bipolar disorder includes a combination of medication and psychotherapy. Yet, little is known about effective psychotherapy approaches for this population, and none expressly target suicidality. An efficacious, cost-effective psychosocial intervention for adolescents with bipolar disorder has great potential to decrease the substantial morbidity, mortality and costs associated with adolescent bipolar disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

November 18, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

6.9 years

First QC Date

December 2, 2013

Last Update Submit

August 9, 2022

Conditions

Keywords

Bipolar disorderAdolescent suicidal behaviorPsychotherapy

Outcome Measures

Primary Outcomes (2)

  • Suicidal events

    Suicidal events as assessed using the C-SSRS

    Over two year follow-up

  • Mood symptoms

    As assessed using the KSADS-MRS and KSADS-DEP-P

    Over two year follow-up

Secondary Outcomes (1)

  • Cost effectiveness

    Over two year follow-up

Study Arms (2)

Dialectical Behavior Therapy + Pharmacotherapy

EXPERIMENTAL

Dialectical Behavior Therapy + Pharmacotherapy

Behavioral: Dialectical Behavior TherapyOther: Pharmacotherapy

Standard of Care Psychotherapy + Pharmacotherapy

ACTIVE COMPARATOR

Standard of Care Psychotherapy + Pharmacotherapy

Behavioral: Standard of Care PsychotherapyOther: Pharmacotherapy

Interventions

Dialectical Behavior Therapy

Dialectical Behavior Therapy + Pharmacotherapy

Standard of Care Psychotherapy

Standard of Care Psychotherapy + Pharmacotherapy

Standard of Care Pharmacotherapy

Dialectical Behavior Therapy + PharmacotherapyStandard of Care Psychotherapy + Pharmacotherapy

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic / University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Goldstein TR, Axelson DA, Birmaher B, Brent DA. Dialectical behavior therapy for adolescents with bipolar disorder: a 1-year open trial. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):820-30. doi: 10.1097/chi.0b013e31805c1613.

  • Goldstein TR, Merranko J, Rode N, Sylvester R, Hotkowski N, Fersch-Podrat R, Hafeman DM, Diler R, Sakolsky D, Franzen P, Birmaher B. Dialectical Behavior Therapy for Adolescents With Bipolar Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Jan 1;81(1):15-24. doi: 10.1001/jamapsychiatry.2023.3399.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Dialectical Behavior TherapyDrug Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesTherapeutics

Study Officials

  • Tina R Goldstein, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 6, 2013

Study Start

November 18, 2014

Primary Completion

September 30, 2021

Study Completion

March 31, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations