Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332098
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2006-05-30
Brief Title:
Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Family-Focused Treatment for Bipolar Adolescents
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of family-focused treatment FFT plus pharmacotherapy in treating adolescents with bipolar disorder
Detailed Description:
Bipolar disorder is a serious mental illness that causes drastic shifts in a persons 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH073871 | NIH | None | None |
| R01MH073817 | NIH | None | None |
| R01MH074033 | NIH | None | None |
| DSIR 84-CTS | REGISTRY | Division of Services and Intervention Research | httpsreporternihgovquickSearchR01MH074033 |