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

Bipolar Disorder Clinical Trial

Official title:

Family-Focused Treatment for Bipolar Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332098
• Other study ID #: R01MH073871
• Secondary ID: R01MH073871R01MH
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2006
• Last updated: May 16, 2014
• Start date: August 2006
• Est. completion date: July 2012

Study information

• Verified date: May 2014
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

Bipolar disorder is a serious mental illness that causes drastic shifts in a person's mood, energy, and ability to function. Bipolar disorder can strike at any age, but it most commonly develops in late adolescence or early adulthood. The disorder is characterized by alternating episodes of mania and depression, often with periods of normal mood in between. Some symptoms of a manic episode include the following behaviors: increased energy, activity, and restlessness; excessively "high," overly good, euphoric mood; and extreme irritability. In contrast, a depressive episode is characterized by a lasting sad, anxious, or empty mood; feelings of hopelessness or pessimism; and decreased energy. Adolescents with bipolar disorder have high rates of disease recurrence, suicide attempts, functional impairment, and mental health service utilization, even with aggressive treatment with mood stabilizers and antipsychotic drugs. Research has suggested that FFT, a behavioral intervention consisting of psychoeducation, communication training, and problem solving training, may lead to improvements in mood symptoms in adolescents with bipolar disorder. This study will evaluate the effectiveness of FFT plus pharmacotherapy in treating adolescents with bipolar illness.

Participants in this 2-year, single-blind study will be randomly assigned to receive a combination of either FFT and pharmacotherapy or enhanced care and pharmacotherapy. 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. All participants will receive pharmacotherapy for the full 2 years. Participants assigned to enhanced care will take part in weekly brief psychoeducation sessions for 3 weeks. 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. Both FFT and enhanced care treatment sessions will include psychoeducation focusing on appropriate ways to manage bipolar disorder and its cycling nature. Crisis intervention sessions will also be offered to all participants on an as-needed basis for the duration of the study. Outcomes, including bipolar disorder symptoms, functioning, and service utilization, will be measured at study visits at Months 3, 6, 9, 12, 18, and 24.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Family-Focused Treatment Plus Pharmacotherapy
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.
• Enhanced Care Plus Pharmacotherapy
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.

Locations

Country	Name	City	State
United States	University of Colorado, Dept. of Psychology	Boulder	Colorado
United States	Cincinnati Children's Hospital Medical Center/MLC 3014	Cincinnati	Ohio
United States	University of Pittsburgh Medical Center Western Psychiatric Institute	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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:S113-28. — View Citation

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;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recovery		Measured at Month 24	No
Primary	Time to recurrence		Measured at Month 24	No
Primary	Severity of manic and depressive symptoms		Measured at Month 24	No
Secondary	Functioning		Measured at Month 24	No
Secondary	Quality of life		Measured at Month 24	No
Secondary	Service utilization		Measured at Month 24	No

External Links

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