Omega-3 Fatty Acids for Treatment of Depression in Adolescents

Phase 3

Completed

• Conditions: Depression
• Interventions: Dietary Supplement: Fish Oil; Behavioral: Cognitive Behavior Therapy; Other: Placebo

• Registration Number: NCT00658476
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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 Selective serotonin reuptake inhibitors (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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-15
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-26
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. 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
2. Diagnosed with major depressive disorder using the DSM-IV diagnostic criteria

Exclusion Criteria

1. Active suicidal ideation, with a current plan and/ or a recent suicide attempt
2. Severe psychotic symptoms (presence of distressing or common hallucinations and/ or delusions)
3. History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, or autism
4. 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)
5. 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
6. Seizure or other neurological disorders
7. Dermatological conditions
8. Unstable cardiac, pulmonary, endocrine, or renal disorder
9. Adolescents who are currently being effectively treated with antidepressants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 Fatty Acids	Fish Oil	Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements.
Omega-3 Fatty Acids	Cognitive Behavior Therapy	Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements.
Placebo	Cognitive Behavior Therapy	Adolescents receive cognitive behavior therapy in combination with placebo.
Placebo	Placebo	Adolescents receive cognitive behavior therapy in combination with placebo.

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	8 times for an average of 8 weeks
Child Depression Inventory - CDI	8 times for an average of 8 weeks

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States