Omega-3 Fatty Acids for Treatment of Depression in Adolescents

Treating Adolescent Depression With Fish Oils

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00658476

Acronym

PUFA

Enrollment

Registered

2008-04-15

Start date

2006-11-30

Completion date

2009-04-30

Last updated

2012-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Adolescent Depression, Depression, Teenage Depression, Los Angeles

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.

Interventions

DIETARY_SUPPLEMENTFish Oil

Omega-3 fatty acid supplements.

BEHAVIORALCognitive Behavior Therapy

Adolescents receive cognitive behavior therapy.

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

13 Years to 21 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026