Ignite Creation Date:
2024-05-06 @ 12:10 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01507753
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2011-08-12
Brief Title:
Omega-3 and Therapy Study for Childhood Bipolar Disorder- Not Otherwise Specified
Sponsor:
L Eugene Arnold
Organization:
Ohio State University
Study Overview
Official Title:
Omega-3 Fatty Acids Psychoeducational Psychotherapy for Childhood Bipolar Disorder- Not Otherwise Specified
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 bipolar disorder- not otherwise specified BP-NOS was originally considered to be a milder version of bipolar disorder BD Research now indicates that BP-NOS is a highly impairing condition No pharmacologic treatment guidelines exist for BP-NOS Available evidence-based pharmacotherapy guidelines are for BP1 efficacious medications are unfortunately associated with significant risk for adverse events Kowatch et al 2005 2009 Previous research on diet and nutrition suggests that omega-3 Ω3 fatty acids have a beneficial effect on mood which might provide either a primary or adjunctive treatment with a more favorable riskbenefit ratio for children suffering from BP-NOS than currently available pharmacologic interventions Psychoeducational psychotherapy PEP also has shown promise in treating bipolar spectrum disorders in children aged 8-12 Fristad 2006 Fristad Verducci Walters Young 2009 its efficacy in treating BP-NOS specifically has not been determined
The current study compares Ω3 PEP and their combination to a placebo supplement and active monitoring AM in a 12-week trial of 60 children with BP-NOS 15 each with Ω3 Ω3 plus PEP PEP and placebo all with active monitoring Primary goals are to determine 1 feasibility of a recruiting 60 participants in 2 years b participant retention over a 12-week trial and 2 placebo-controlled effect sizes for Ω3 PEP and combination treatment on manic and depressive symptoms Secondary goals are to explore response curves over time mediators and moderators treatment response across a broad array of outcome variables adherence to treatment impact on physiologic parameters often worsened by mood stabilizing medications and experience of side-effects in participants receiving Ω3 andor PEP Comparisons of results to a parallel study of children with depression with identical design will maximize knowledge gained This pilot study of Ω3 PEP and combined treatment will provide evidence about whether a larger trial is feasible and justified
The current study compares Ω3 PEP and their combination to a placebo supplement and active monitoring AM in a 12-week trial of 60 children with BP-NOS 15 each with Ω3 Ω3 plus PEP PEP and placebo all with active monitoring Primary goals are to determine 1 feasibility of a recruiting 60 participants in 2 years b participant retention over a 12-week trial and 2 placebo-controlled effect sizes for Ω3 PEP and combination treatment on manic and depressive symptoms Secondary goals are to explore response curves over time mediators and moderators treatment response across a broad array of outcome variables adherence to treatment impact on physiologic parameters often worsened by mood stabilizing medications and experience of side-effects in participants receiving Ω3 andor PEP Comparisons of results to a parallel study of children with depression with identical design will maximize knowledge gained This pilot study of Ω3 PEP and combined treatment will provide evidence about whether a larger trial is feasible and justified
Detailed Description:
Research indicates BP-NOS is a highly impairing condition comparable to the other bipolar spectrum disorders Considerable gains have been made recently in understanding BP-NOS in large part by research utilizing clear operational definitions for BP-NOS However clinical trials have focused on youth with Bipolar Disorder- Type I BP1 No clinical guidelines exist for the treatment of BP-NOS
No pharmacologic treatment guidelines exist for BP-NOS Available evidence-based pharmacotherapy guidelines are for BP1 and are associated with significant risk for adverse events Additionally while anti-manic agents have been identified no study has demonstrated an effective anti-depressant agent for youth with bipolar depression A review of weight gain and metabolic side effects of mood stabilizers and antipsychotic medications in 19 studies of pediatric bipolar patients found significant and clinically relevant weight increases in 18 trials Clinical trials of depression and bipolar disorders in children and adolescents show approximately 20-25 of participants dropped out of short-term psychotropic medication treatment trials Additionally a recent study of an anticonvulsant mood stabilizer in children failed to show any superiority to placebo
Previous research on diet and nutrition suggests that omega-3 Ω3 fatty acids have a beneficial effect on mood with little evidence of negative side-effects or deleterious drug interactions suggesting Ω3 might function as either a primary or adjunctive treatment with a more favorable risk-benefit ratio for children suffering from BP than currently available pharmacologic interventionsPsychoeducational psychotherapy PEP also has shown promise in treating bipolar spectrum disorders in children aged 8-12 its efficacy in treating BP-NOS specifically has not been determined
The current study compares Ω3 PEP and their combination to a placebo supplement all with active monitoring AM in a 12-week trial of 60 children with BP-NOS 15 each with Ω3 Ω3 plus PEP PEP and placebo Primary goals are to determine 1 feasibility of a recruiting 60 participants in 2 years b participant retention over a 12-week trial and 2 placebo-controlled effect sizes for Ω3 PEP and combination treatment on manic and depressive symptoms Secondary goals are to explore response curves over time mediators and moderators treatment response across a broad array of outcome variables adherence to treatment impact on physiologic parameters often worsened by mood stabilizing medications and experience of side-effects in participants receiving Ω3 andor PEP Comparisons of results to a parallel study of children with depression with identical design will maximize knowledge gained This pilot study of Ω3 PEP and combined treatment will provide evidence about whether a larger trial is feasible and justified
No pharmacologic treatment guidelines exist for BP-NOS Available evidence-based pharmacotherapy guidelines are for BP1 and are associated with significant risk for adverse events Additionally while anti-manic agents have been identified no study has demonstrated an effective anti-depressant agent for youth with bipolar depression A review of weight gain and metabolic side effects of mood stabilizers and antipsychotic medications in 19 studies of pediatric bipolar patients found significant and clinically relevant weight increases in 18 trials Clinical trials of depression and bipolar disorders in children and adolescents show approximately 20-25 of participants dropped out of short-term psychotropic medication treatment trials Additionally a recent study of an anticonvulsant mood stabilizer in children failed to show any superiority to placebo
Previous research on diet and nutrition suggests that omega-3 Ω3 fatty acids have a beneficial effect on mood with little evidence of negative side-effects or deleterious drug interactions suggesting Ω3 might function as either a primary or adjunctive treatment with a more favorable risk-benefit ratio for children suffering from BP than currently available pharmacologic interventionsPsychoeducational psychotherapy PEP also has shown promise in treating bipolar spectrum disorders in children aged 8-12 its efficacy in treating BP-NOS specifically has not been determined
The current study compares Ω3 PEP and their combination to a placebo supplement all with active monitoring AM in a 12-week trial of 60 children with BP-NOS 15 each with Ω3 Ω3 plus PEP PEP and placebo Primary goals are to determine 1 feasibility of a recruiting 60 participants in 2 years b participant retention over a 12-week trial and 2 placebo-controlled effect sizes for Ω3 PEP and combination treatment on manic and depressive symptoms Secondary goals are to explore response curves over time mediators and moderators treatment response across a broad array of outcome variables adherence to treatment impact on physiologic parameters often worsened by mood stabilizing medications and experience of side-effects in participants receiving Ω3 andor PEP Comparisons of results to a parallel study of children with depression with identical design will maximize knowledge gained This pilot study of Ω3 PEP and combined treatment will provide evidence about whether a larger trial is feasible and justified
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 |
|---|---|---|---|
| 1R34MH090148-01A1 | NIH | None | httpsreporternihgovquickSearch1R34MH090148-01A1 |