Omega-3 Fatty Acids in Adolescent Depression - Full Text View

Sponsors and Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) National Center for Research Resources (NCRR)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00312897

Purpose

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	Intervention
Adolescent Depression	Drug: Omega-3 Fatty Acids (fish oil)

MedlinePlus related topics: Depression

Drug Information available for: Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Omega-3 Fatty Acids in Adolescent Depression

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Children's Depressive Rating Scale Revised
Clinical Global Improvement Scale

Estimated Enrollment:	40
Study Start Date:	December 2005
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Ages Eligible for Study:	12 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age: 12-19
Depressed with DSM-IV diagnosis of MDD
Duration of depressive episode greater than 6 weeks

Exclusion Criteria:

Current or past DSM-IV-TR bipolar, schizophrenia, psychosis, pervasive developmental disorder (PDD), and Tourette's disorder.
Current diagnosis of eating, panic, conduct, obsessive compulsive, post traumatic stress, and/or substance-related disorders (other than nicotine).
Adolescents who present with current suicidal ideation with intent or plan, or who may pose a danger to themselves.
Current antidepressant treatment, or taken within 60 days prior to enrollment
Neuroleptics taken within 90 days prior to enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312897

Contacts

Contact: Vilma Gabbay, M.D.	212-263-6622 ext 2731	vilma.gabbay@med.nyu.edu
Contact: Julia Perault, B.A.	212-263-6622 ext 2494	julia.perault@med.nyu.edu

Locations

United States, New York
New York University Child Study Center	Recruiting
New York, New York, United States, 10016
Contact: Vilma Gabbay, M.D. 212-263-6622 ext 2731 vilma.gabbay@med.nyu.edu
Contact: Lucy Buchholz 212-263-6622 ext 3654 lucy.buchholz@med.nyu.edu
Sub-Investigator: Carmen Alonso, M.D.
Sub-Investigator: Raul Silva, M.D.

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:

Vilma Gabbay, M.D.

NYU Child Study Center/ New York University School of Medicine

More Information

Study ID Numbers:	R21 AT002395-01A2
Study First Received:	April 7, 2006
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00312897
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Adolescents
Depression
Fish Oil
Omega-3 Fatty Acids
Psychiatry

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009