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Bipolar DisorderPhase 3NCT00332098

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

A Phase 3 study testing Family-Focused Treatment Plus Pharmacotherapy and Enhanced Care Plus Pharmacotherapy in people with Bipolar Disorder, run by University of California, Los Angeles at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Bipolar Disorder
What is being tested?
Family-Focused Treatment Plus Pharmacotherapy and Enhanced Care Plus Pharmacotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
3 sitesUnited States
Study dates
Aug 2006to Jul 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • University of Colorado, Dept. of Psychology

    Boulder, Colorado, 80309-0345

  • Cincinnati Children's Hospital Medical Center/MLC 3014

    Cincinnati, Ohio, 45229

  • University of Pittsburgh Medical Center Western Psychiatric Institute

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Family-Focused Treatment for Bipolar Adolescents

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

Read the detailed 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.

Being tested
Family-Focused Treatment Plus Pharmacotherapy, Enhanced Care Plus Pharmacotherapy
Keywords
Childhood Mood Disorders, Family Treatment, Psychoeducation, Pharmacotherapy, Family Functioning, Psychosocial Intervention
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family-Focused Treatment Plus PharmacotherapyBehavioural

    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 PharmacotherapyBehavioural

    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.

Study groups in NCT00332098
Study groupRoleWhat they receive
1ExperimentalFamily-Focused Treatment Plus Pharmacotherapy
Receives: Behavioral: Family-Focused Treatment Plus Pharmacotherapy
2Active comparatorEnhanced Care Plus Pharmacotherapy
Receives: Behavioral: Enhanced Care Plus Pharmacotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to recovery

    Measured: Measured at Month 24

  2. Time to recurrence

    Measured: Measured at Month 24

  3. Severity of manic and depressive symptoms

    Measured: Measured at Month 24

Secondary outcomes (3)
  1. Functioning

    Measured: Measured at Month 24

  2. Quality of life

    Measured: Measured at Month 24

  3. Service utilization

    Measured: Measured at Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00332098
Sponsor's protocol ID
R01MH073871
Other IDs
R01MH073871, R01MH073817, R01MH074033, DSIR 84-CTS
Status last verified
May 2014
First submitted
30 May 2006
Last updated
20 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15571785
  • 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.

    PubMed 18762591
  • 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.

    PubMed 24626789
  • 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.

    PubMed 32012257
  • 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.

    PubMed 31150753
  • 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.

    PubMed 28570966
  • 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.

    PubMed 23021483

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Family-Focused Treatment Plus Pharmacotherapy and Enhanced Care Plus Pharmacotherapy in people with Bipolar Disorder, run by University of California, Los Angeles at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to recovery (time frame: Measured at Month 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00332098, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.

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