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OpenTrials
Completed

NCT Number: NCT00658476

Omega-3 Fatty Acids for Treatment of Depression in Adolescents

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

Omega-3 fatty acid supplements.

Cognitive Behavior Therapy

Behavioral

Adolescents receive cognitive behavior therapy.

Placebo

Other

Primary outcomes

  1. Child Depression Inventory - CDI

    Time frame: 8 times for an average of 8 weeks

  2. Hamilton Depression Rating Scale

    Time frame: 8 times for an average of 8 weeks

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Official study title

Treating Adolescent Depression With Fish Oils

Acronym: PUFA

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 15, 2008
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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