| City: |
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Cincinnati |
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State:
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OH |
| Zip Code: |
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45229 |
| Conditions: |
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Bipolar Disorder |
| Purpose: |
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This study will evaluate the effectiveness of family-focused treatment (FFT) plus
pharmacotherapy in treating adolescents with bipolar disorder.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Cincinnati Children's Hospital Medical Center/MLC 3014
Cincinnati, OH 45229
United States
Primary Contact:
Robert A. Kowatch, MD
Email: robert.kowatch@cchmc.org
Phone: 513-636-0024
Secondary Contact:
David J. Miklowitz, PhD
Email: miklow@psych.colorado.edu
Phone: 303-492-8575 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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