Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312897
Status:
COMPLETED
Last Update Posted:
2018-04-19
First Post:
2006-04-07
Brief Title:
Omega-3 Fatty Acids in Adolescent Depression
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Omega-3 Fatty Acids in Adolescent Depression
Status:
COMPLETED
Status Verified Date:
2018-03
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:
None
Brief Summary:
Aim To provide preliminary data about the efficacy of omega-3FA in the treatment of adolescent MDD To address this aim a 10-week double blind placebo-controlled study of omega-3FA using a flexible dose titration is proposed Primary outcome measures will be 1 change in the total score of the Childrens Depression Rating Scale-Revised CDRS-R at the end of treatment 2 response rate on the Clinical Global Improvement scale CGI at the end of 10-week treatment
Hypothesis Omega-3FA treatment in adolescents with MDD will result in a significant reduction of CDRS-R total scores and a significantly higher improvement rate on the CGI at the end of treatment compared to placebo
Hypothesis Omega-3FA treatment in adolescents with MDD will result in a significant reduction of CDRS-R total scores and a significantly higher improvement rate on the CGI at the end of treatment compared to placebo
Detailed Description:
Title Omega-3 Fatty Acids in Adolescents with Depression
NOTE No individual will be advised to terminate ongoing treatment If adolescents have been in psychotherapy prior to their entry in the study they will be allowed to continue with the treatment However psychotherapy cannot be initiated at the time of entry into the study
Aim To provide preliminary clinical data about the efficacy of omega-3FA derived from fish oil in the treatment of adolescent MDD A NCCAMNIH-funded study
Summary Informed consent will be obtained from parentguardian and assent obtained from participant Interested participants will have a free diagnostic evaluation by study psychiatrist to determine eligibility Routine blood tests and a urine pregnancy test will be obtained Eligible participants will be randomized to receive either omega-3FA or matching placebo corn oil for 10 weeks Patients will be seen weekly throughout the trial Dosage will be titrated based on clinical response and side effects At end of double-blind phase participants will be referred to a clinician who will be informed of subjects treatment Depending on treatment received during double-blind phase post-study treatment options will include treatment with omega-3 fatty acids or an SSRI
NOTE No individual will be advised to terminate ongoing treatment If adolescents have been in psychotherapy prior to their entry in the study they will be allowed to continue with the treatment However psychotherapy cannot be initiated at the time of entry into the study
Aim To provide preliminary clinical data about the efficacy of omega-3FA derived from fish oil in the treatment of adolescent MDD A NCCAMNIH-funded study
Summary Informed consent will be obtained from parentguardian and assent obtained from participant Interested participants will have a free diagnostic evaluation by study psychiatrist to determine eligibility Routine blood tests and a urine pregnancy test will be obtained Eligible participants will be randomized to receive either omega-3FA or matching placebo corn oil for 10 weeks Patients will be seen weekly throughout the trial Dosage will be titrated based on clinical response and side effects At end of double-blind phase participants will be referred to a clinician who will be informed of subjects treatment Depending on treatment received during double-blind phase post-study treatment options will include treatment with omega-3 fatty acids or an SSRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| R21AT002395-01A2 | NIH | None | httpsreporternihgovquickSearchR21AT002395-01A2 |