Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents

NCT00332098 | Completed Phase 3 DMC

• 4 other identifiers: R01MH073871R01MH073817R01MH074033DSIR 84-CTS
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the effectiveness of family-focused treatment (FFT) plus pharmacotherapy in treating adolescents with bipolar disorder.

Conditions

Bipolar Disorder

Keywords

Childhood Mood Disorders; Family Treatment; Psychoeducation; Pharmacotherapy; Family Functioning; Psychosocial Intervention

Outcome Measures

Primary Outcomes (3)

• Time to recovery

  Measured at Month 24

• Time to recurrence

  Measured at Month 24

• Severity of manic and depressive symptoms

  Measured at Month 24

Secondary Outcomes (3)

• Functioning

  Measured at Month 24

• Quality of life

  Measured at Month 24

• Service utilization

  Measured at Month 24

Study Arms (2)

1

EXPERIMENTAL

Family-Focused Treatment Plus Pharmacotherapy

Behavioral: Family-Focused Treatment Plus Pharmacotherapy

2

ACTIVE COMPARATOR

Enhanced Care Plus Pharmacotherapy

Behavioral: Enhanced Care Plus Pharmacotherapy

Interventions

Family-Focused Treatment Plus Pharmacotherapy BEHAVIORAL

Participants assigned to FFT will take part in weekly treatment sessions with their families for 12 weeks, biweekly for 12 weeks, monthly for 3 months, and then trimonthly until Month 24. Medications used for the pharmacotherapy portion of the study will include mood stabilizers, such as lithium or divalproex sodium, and atypical antipsychotics, such as quetiapine. Participants will also receive anti-anxiety medications, psychostimulants, or antidepressants as needed.

1

Enhanced Care Plus Pharmacotherapy BEHAVIORAL

Participants assigned to Enhanced Care will take part in weekly brief psychoeducation sessions for 3 weeks. The pharmacotherapy treatment will be the same as for the FFT participants.

2

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between the ages of 13 years, 0 months and 17 years, 11 months
• Meets The Diagnostic and Statistical Manual of Mental Disorders - IV criteria for either of the following conditions: bipolar I or bipolar II disorder with a manic, mixed, or hypomanic episode within 3 months of study entry; or a depressed episode within 3 months of study entry with a prior history of a manic, hypomanic, or mixed episode (if the participant only meets criteria for a current hypomanic episode, there must also be a history of at least one prior depressive, manic, or mixed episode)
• Has experienced severe depression, hypomania, or mania symptoms for a period of at least 1 week within the 3 months prior to study entry
• Lives with at least one biological or step-parent who is available and willing to participate in treatment (parents not currently living with the adolescent participant may also participate)

You may not qualify if:

• Currently in full recovery (experienced minimal symptoms for at least 8 continuous weeks)
• Meets Diagnostic and Statistical Manual of Mental Disorders, IV criteria for substance abuse disorder or substance dependence disorder within 3 months of study entry (based on the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version )
• Meets current criteria for bipolar, not otherwise specified, or substance-induced mood disorder
• Diagnosis of mental retardation, autism, or organic central nervous system disorder
• Severe, unremitting psychosis that is unresponsive to neuroleptic medications, and has lasted more than 3 months
• Requires extended inpatient treatment (although participant can be hospitalized at the time of intake into the study)
• Current life-threatening eating disorder, neurological condition, or other medical problem that requires immediate treatment
• Exhibits or expresses serious homicidal tendencies
• Victim of current sexual or physical abuse by parents or is in an environment marked by domestic violence among the parents or step-parents

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

University of Colorado, Dept. of Psychology

Boulder, Colorado, 80309-0345, United States

Location

Cincinnati Children's Hospital Medical Center/MLC 3014

Cincinnati, Ohio, 45229, United States

Location

University of Pittsburgh Medical Center Western Psychiatric Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

• Miklowitz DJ, George EL, Axelson DA, Kim EY, Birmaher B, Schneck C, Beresford C, Craighead WE, Brent DA. Family-focused treatment for adolescents with bipolar disorder. J Affect Disord. 2004 Oct;82 Suppl 1(Suppl 1):S113-28. doi: 10.1016/j.jad.2004.05.020.

  PMID: 15571785 BACKGROUND

• Miklowitz DJ, Axelson DA, Birmaher B, George EL, Taylor DO, Schneck CD, Beresford CA, Dickinson LM, Craighead WE, Brent DA. Family-focused treatment for adolescents with bipolar disorder: results of a 2-year randomized trial. Arch Gen Psychiatry. 2008 Sep;65(9):1053-61. doi: 10.1001/archpsyc.65.9.1053.

  PMID: 18762591 BACKGROUND

• Miklowitz DJ, Schneck CD, George EL, Taylor DO, Sugar CA, Birmaher B, Kowatch RA, DelBello MP, Axelson DA. Pharmacotherapy and family-focused treatment for adolescents with bipolar I and II disorders: a 2-year randomized trial. Am J Psychiatry. 2014 Jun;171(6):658-67. doi: 10.1176/appi.ajp.2014.13081130.

  PMID: 24626789 RESULT

• O'Donnell LA, Weintraub MJ, Ellis AJ, Axelson DA, Kowatch RA, Schneck CD, Miklowitz DJ. A Randomized Comparison of Two Psychosocial Interventions on Family Functioning in Adolescents with Bipolar Disorder. Fam Process. 2020 Jun;59(2):376-389. doi: 10.1111/famp.12521. Epub 2020 Feb 3.

  PMID: 32012257 DERIVED

• Weintraub MJ, Schneck CD, Axelson DA, Birmaher B, Kowatch RA, Miklowitz DJ. Classifying Mood Symptom Trajectories in Adolescents With Bipolar Disorder. J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):381-390. doi: 10.1016/j.jaac.2019.04.028. Epub 2019 May 28.

  PMID: 31150753 DERIVED

• O'Donnell LA, Axelson DA, Kowatch RA, Schneck CD, Sugar CA, Miklowitz DJ. Enhancing quality of life among adolescents with bipolar disorder: A randomized trial of two psychosocial interventions. J Affect Disord. 2017 Sep;219:201-208. doi: 10.1016/j.jad.2017.04.039. Epub 2017 Apr 28.

  PMID: 28570966 DERIVED

• Keenan-Miller D, Peris T, Axelson D, Kowatch RA, Miklowitz DJ. Family functioning, social impairment, and symptoms among adolescents with bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2012 Oct;51(10):1085-94. doi: 10.1016/j.jaac.2012.08.005. Epub 2012 Aug 28.

  PMID: 23021483 DERIVED

Related Links

• Robert Sutherland Center for the Evaluation and Treatment of Bipolar Disorder, University of Colorado, Boulder

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• David J. Miklowitz, PhD

  University of Colorado at Boulder

  PRINCIPAL INVESTIGATOR

• Robert A. Kowatch, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• David A. Axelson, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: June 1, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

US (3)