Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01341925
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2011-04-22
Brief Title:
Omega-3 and Therapy Study for Depression
Sponsor:
L Eugene Arnold
Organization:
Ohio State University
Study Overview
Official Title:
Omega-3 Fatty Acids Psychoeducational Psychotherapy for Childhood Depression
Status:
COMPLETED
Status Verified Date:
2016-03
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:
OATS
Brief Summary:
Childhood depression warrants treatment research including pharmacological and psychotherapeutic interventions A recent study found fluoxetine to be the only medication with empirical support for decreasing depression in children but concerns about treatment-emergent suicidal ideationbehavior led the FDA to mandate black-box warning for use of antidepressants in this age group Bridge et al 2007 These worries have prompted interest in alternative therapies including dietary supplements such as omega-3 fatty acids Ω3
The current study compares Ω3 psychoeducational psychotherapy PEP and their combination to a placebo supplement and active monitoring AM in a 12-week trial of 60 children with unipolar depression Primary goals are to determine 1 feasibility of a recruiting 60 participants in 24 months b retaining participants over a 12-week trial and 2 effect sizes for Ω3 PEP and combination treatment Secondary goals are to explore response curves over time mediators and moderators treatment response across an array of outcome variables adherence to treatment and side effects This pilot study of Ω3 PEP and combined treatment will provide evidence about whether a larger trial is feasible and justifiable
The current study compares Ω3 psychoeducational psychotherapy PEP and their combination to a placebo supplement and active monitoring AM in a 12-week trial of 60 children with unipolar depression Primary goals are to determine 1 feasibility of a recruiting 60 participants in 24 months b retaining participants over a 12-week trial and 2 effect sizes for Ω3 PEP and combination treatment Secondary goals are to explore response curves over time mediators and moderators treatment response across an array of outcome variables adherence to treatment and side effects This pilot study of Ω3 PEP and combined treatment will provide evidence about whether a larger trial is feasible and justifiable
Detailed Description:
Approximately 2 to 4 of children experience either major depressive disorder or dysthymic disorder and 5 to 10 of children and adolescents experience subsyndromal depressive symptoms Birmaher et al Due to its prevalence and association with significant functioning deficits childhood depression warrants treatment research Treatments include pharmacological and psychotherapeutic interventions A recent meta-analysis found fluoxetine to be the only medication with empirical support for decreasing depression in children but concerns about treatment-emergent suicidal ideationbehavior led the FDA to mandate black-box warning for use of antidepressants in this age group Bridge et al 2007 These worries have prompted interest in alternative therapies including dietary supplements such as omega-3 fatty acids Ω3 Research on treatment of mood disorders with Ω3 is promising Schacter et al 2005 however only one RCT has been conducted in children which was positive Nemets et al 2006 Findings from other clinical populations ADHD adolescent depression anxiety and pervasive developmental disorders in children suggest combination treatments are advantageous Aman et al 2009 The MTA Cooperative Group 1999 2004 The TADS Team 2007 Walkup et al 2008 Little is known about the effectiveness of psychotherapy for children age 12 and under who are clinically depressed Researchers are beginning to develop and test manual-based individualfamily therapies for clinic-referred children with diagnosable depression Kovacs et al 2006 Tompson et al 2007 however no RCTs have been completed Prior research supports incorporating psychoeducation about depression support and skill building to decrease depressive symptoms Birmaher et al
The current study compares Ω3 psychoeducational psychotherapy PEP and their combination to a placebo supplement and active monitoring AM in a 12-week trial of 60 children with unipolar depression Primary goals are to determine 1 feasibility of a recruiting 60 participants in 24 months b retaining participants over a 12-week trial and 2 effect sizes for Ω3 PEP and combination treatment Secondary goals are to explore response curves over time mediators and moderators treatment response across an array of outcome variables adherence to treatment and side effects This pilot study of Ω3 PEP and combined treatment will provide evidence about whether a larger trial is feasible and justifiable
The current study compares Ω3 psychoeducational psychotherapy PEP and their combination to a placebo supplement and active monitoring AM in a 12-week trial of 60 children with unipolar depression Primary goals are to determine 1 feasibility of a recruiting 60 participants in 24 months b retaining participants over a 12-week trial and 2 effect sizes for Ω3 PEP and combination treatment Secondary goals are to explore response curves over time mediators and moderators treatment response across an array of outcome variables adherence to treatment and side effects This pilot study of Ω3 PEP and combined treatment will provide evidence about whether a larger trial is feasible and justifiable
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 |
|---|---|---|---|
| 1R34MH085875-01A2 | NIH | None | httpsreporternihgovquickSearch1R34MH085875-01A2 |