Omega-3 Fatty Acids in Adolescent Depression
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|ClinicalTrials.gov Identifier: NCT00312897|
Recruitment Status : Completed
First Posted : April 11, 2006
Results First Posted : February 15, 2018
Last Update Posted : April 19, 2018
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 Children's 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.
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Depression||Drug: Omega-3 Fatty Acids Drug: corn oil||Phase 2|
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 NCCAM/NIH-funded study.
Summary: Informed consent will be obtained from parent/guardian 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Omega-3 Fatty Acids in Adolescent Depression|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Placebo Comparator: corn oil
Drug: corn oil
Experimental: Omega 3 Fatty Acids
Drug: Omega-3 Fatty Acids
10 wk treatment period
Other Name: fish oil
- Children's Depressive Rating Scale - Revised (CDRS-R) [ Time Frame: baseline and 10-weeks ]It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms).
- Clinician's Global Improvement Scale (CGI) [ Time Frame: baseline and 10-week treatment phase ]a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312897
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Vilma Gabbay, M.D.||Icahn School of Medicine at Mount Sinai|