Omega-3 Fatty Acids for Treatment of Depression in Adolescents

Depression Clinical Trial

— PUFA  

Official title:

Treating Adolescent Depression With Fish Oils

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658476
• Other study ID #: 9407
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2008
• Last updated: March 26, 2012
• Start date: November 2006
• Est. completion date: April 2009

Study information

• Verified date: March 2012
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 21 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Dietary Supplement:
• Fish Oil
Omega-3 fatty acid supplements.

Behavioral:
• Cognitive Behavior Therapy
Adolescents receive cognitive behavior therapy.

Other:
• Placebo

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Depression Inventory - CDI		8 times for an average of 8 weeks	No
Primary	Hamilton Depression Rating Scale		8 times for an average of 8 weeks	No