Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511810
Status:
COMPLETED
Last Update Posted:
2016-05-27
First Post:
2007-08-03
Brief Title:
Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
Evaluation of Omega-3 Fatty Acids as a Treatment-adjunct in Adolescent Patients With Major Depressive Disorder Exhibiting Partial Response to SSRI Medications An Open-label Neuroimaging Trial
Status:
COMPLETED
Status Verified Date:
2016-04
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:
The primary objective of the study was to determine the effects of 10-week adjunctive supplementation with 2 doses of LCn-3 fatty acids fish oil on cortical functional activity and biochemistry in adolescents with MDD
The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently increase prefrontal cortical functional activation during sustained attention and increase regional biochemical indices of cortical metabolism and integrity concentrations in association with reductions in depressive symptoms
The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently increase prefrontal cortical functional activation during sustained attention and increase regional biochemical indices of cortical metabolism and integrity concentrations in association with reductions in depressive symptoms
Detailed Description:
This study is a 10-week open-label EPADHA treatment trial in adolescent aged 12-18 years patients with major depressive disorder exhibiting partial response to SSRI medications After a screening visit patients were randomized stratified by gender to open-label fish oil supplements at a fixed dose of either 24 gday or 15 gday 2 tablespoonsday for 10 weeks
A physical examination a complete blood count CBC and thyroid stimulating hormone TSH levels were determined at baseline and Week 10 and vital signs pulse blood pressure weight height body mass index temperature were obtained at each visit At each visit safety and tolerability were assessed using a structured side effect interview the Side Effects Form for Children and Adolescents
At baseline and all weekly visits depression symptom severity was determined with the Childrens Depression Rating Scale-Revised CDRS-R a 17-item observer-rated questionnaire and remission was defined as a CDRS-R score of 28 If a patients depressive symptoms worsened over the course of the trial defined as 30 worsening relative to baseline on two consecutive visits using CDRS-R scores they were withdrawn from the study In view of the potential risk for developing hypomanic symptoms following LCn-3 fatty acid supplementation manic symptom severity was monitored over the course of the trial with the Young Mania Rating Scale YMRS an 11-item observer-rated questionnaire
fMRI scans were performed at baseline and at 10 weeks
A physical examination a complete blood count CBC and thyroid stimulating hormone TSH levels were determined at baseline and Week 10 and vital signs pulse blood pressure weight height body mass index temperature were obtained at each visit At each visit safety and tolerability were assessed using a structured side effect interview the Side Effects Form for Children and Adolescents
At baseline and all weekly visits depression symptom severity was determined with the Childrens Depression Rating Scale-Revised CDRS-R a 17-item observer-rated questionnaire and remission was defined as a CDRS-R score of 28 If a patients depressive symptoms worsened over the course of the trial defined as 30 worsening relative to baseline on two consecutive visits using CDRS-R scores they were withdrawn from the study In view of the potential risk for developing hypomanic symptoms following LCn-3 fatty acid supplementation manic symptom severity was monitored over the course of the trial with the Young Mania Rating Scale YMRS an 11-item observer-rated questionnaire
fMRI scans were performed at baseline and at 10 weeks
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