Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents
NCT ID: NCT00332098
Last Updated: 2014-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
145 participants
INTERVENTIONAL
2006-08-31
2012-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluating the Effectiveness of Family-Focused Psychoeducation in Treating Adolescents With Bipolar Disorder
NCT00571402
Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder
NCT00943085
Brief Motivational Intervention to Improve Medication Adherence for Adolescents With Bipolar Disorder
NCT03203720
Early Intervention for Youth at Risk for Bipolar Disorder
NCT01483391
Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
NCT00338806
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Family-Focused Treatment Plus Pharmacotherapy
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.
2
Enhanced Care Plus Pharmacotherapy
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
13 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
University of California, Los Angeles
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David J. Miklowitz, Ph.D.
Professor of Psychiatry
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David J. Miklowitz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado at Boulder
Robert A. Kowatch, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
David A. Axelson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Robert Sutherland Center for the Evaluation and Treatment of Bipolar Disorder, University of Colorado, Boulder
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DSIR 84-CTS
Identifier Type: REGISTRY
Identifier Source: secondary_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.