Omega-3 Fatty Acids for Treatment of Depression in Adolescents - Full Text View

Purpose

Adolescence is the highest risk period for depression onset. More than 1.3 million youths suffer from major depression annually in the United States, and there is evidence for an increasing trend. Because many adolescents have their first depressive episode in adolescence and adolescent depression often leads to recurrent mood disorders in adults, effective treatment during early illness can minimize the negative consequences of initial and repeated episodes. Although some antidepressants (particularly SSRIs) are effective treatments for juvenile depression, recent warnings about suicide and the use of SSRls highlight the need for new and safe treatment for juvenile depression. Data in adults suggest that supplementation with polyunsaturated fatty acids (PUFA) might be useful for the treatment of depression. The purpose of this study is to investigate the safety and efficacy of PUFA for the treatment of adolescent depression.

Condition	Intervention	Phase
Depression	Other: Combination Cognitive Behavior Therapy and Fish Oil Behavioral: Cognitive Behavior Therapy	Phase III

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Treating Adolescent Depression With Fish Oils

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:

Child Depression Inventory - CDI [ Time Frame: 1 wk ] [ Designated as safety issue: No ]
Ham-D [ Time Frame: 1 wk ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements.	Other: Combination Cognitive Behavior Therapy and Fish Oil Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements.
2: Placebo Comparator Adolescents receive cognitive behavior therapy in combination with placebo	Behavioral: Cognitive Behavior Therapy Adolescents receive cognitive behavior therapy in combination with placebo

Eligibility

Ages Eligible for Study:	13 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adolescents between the ages of 13 and 21 currently under standard of care treatment at the Child Division of the Department of Psychiatry at CSMC
Diagnosed with major depressive disorder using the DSM-IV diagnostic criteria

Exclusion Criteria:

Active suicidal ideation, with a current plan and/ or a recent suicide attempt
Severe psychotic symptoms (presence of distressing or common hallucinations and/ or delusions)
History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, or autism
Potential subjects using psychotropic medication(s), alcohol, and/ or drugs within 2 weeks prior to entry into the study (8 weeks for fluoxetine and MAOIs - monoamine oxidase inhibitors)
Pregnant or lactating females, or those who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy) and become pregnant.
Seizure or other neurological disorders
Dermatological conditions
Unstable cardiac, pulmonary, endocrine, or renal disorder
Adolescents who are currently being effectively treated with antidepressants

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658476

Contacts


Contact: Lana Levi, B.S.	310-423-0744	LeviL@cshs.org

Locations


United States, California
	Cedars-Sinai Medical Center	Recruiting
	Los Angeles, California, United States, 90048
	Principal Investigator: Syed Naqvi, M.D.

Sponsors and Collaborators

Cedars-Sinai Medical Center

National Alliance for Research on Schizophrenia and Depression

Investigators


Principal Investigator:	Sayed Naqvi, M.D.	Cedars-Sinai Medical Center

More Information

Cedars-Sinai Medical Center Psychiatry Research HomePage This link exits the ClinicalTrials.gov site

Responsible Party:	Cedars-Sinai Medical Center ( Dr. Sayed Naqvi, M.D. )
Study ID Numbers:	9407
First Received:	April 8, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00658476
Health Authority:	United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:

Adolescent Depression

Depression

Teenage Depression

Los Angeles

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Depressive Disorder

Behavioral Symptoms

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	Cedars-Sinai Medical Center National Alliance for Research on Schizophrenia and Depression
Information provided by:	Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00658476