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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
David Miklowitz, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00332098
First received: May 30, 2006
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Bipolar Disorder
Behavioral: Family-Focused Treatment Plus Pharmacotherapy
Behavioral: Enhanced Care Plus Pharmacotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family-Focused Treatment for Bipolar Adolescents

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Time to recovery [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Time to recurrence [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Severity of manic and depressive symptoms [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functioning [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Service utilization [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2006
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Family-Focused Treatment Plus Pharmacotherapy
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.
Active Comparator: 2
Enhanced Care Plus Pharmacotherapy
Behavioral: Enhanced Care Plus Pharmacotherapy
Participants assigned to EC will take part in weekly brief psychoeducation sessions for 3 weeks. The pharmacotherapy treatment will be the same as for the FTT participants.

Detailed Description:

Bipolar disorder (BPD) is a serious mental illness that causes drastic shifts in a person's mood, energy, and ability to function. BPD 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 BPD 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 BPD symptoms in adolescents. This study will evaluate the effectiveness of FFT plus pharmacotherapy in treating adolescents with BPD.

Participants in this 2-year, single-blind study will be randomly assigned to receive a combination of either FFT and pharmacotherapy or enhanced care (EC) 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 EC 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 EC treatment sessions will include psychoeducation focusing on appropriate ways to manage BPD 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 BPD symptoms, functioning, and service utilization, will be measured at study visits at Months 3, 6, 9, 12, 18, and 24.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 13 years, 0 months and 17 years, 11 months
  • Meets DSM-IV-TR 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 DSM-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 [KSADS-PL])
  • Meets current criteria for bipolar, not otherwise specified, or substance-induced mood disorder
  • Diagnosis of mental retardation (as defined by an IQ less than 70), 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332098

Locations
United States, Colorado
University of Colorado, Dept. of Psychology
Boulder, Colorado, United States, 80309-0345
United States, Ohio
Cincinnati Children's Hospital Medical Center/MLC 3014
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
University of Pittsburgh Medical Center Western Psychiatric Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Miklowitz, Professor of Psychiatry, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00332098     History of Changes
Other Study ID Numbers: R01 MH073871, R01MH073817, R01MH074033, DSIR 84-CTS
Study First Received: May 30, 2006
Last Updated: December 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Childhood Mood Disorders
Family Treatment
Psychoeducation
Pharmacotherapy
Family Functioning
Psychosocial Intervention

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014