Omega-3 Fatty Acids for Treatment of Depression in Adolescents (PUFA)

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00658476
First received: April 8, 2008
Last updated: March 26, 2012
Last verified: March 2012
  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 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.


Condition Intervention Phase
Depression
Dietary Supplement: Fish Oil
Behavioral: Cognitive Behavior Therapy
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Adolescent Depression With Fish Oils

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Child Depression Inventory - CDI [ Time Frame: 8 times for an average of 8 weeks ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale [ Time Frame: 8 times for an average of 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: November 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega-3 Fatty Acids
Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements.
Dietary Supplement: Fish Oil
Omega-3 fatty acid supplements.
Behavioral: Cognitive Behavior Therapy
Adolescents receive cognitive behavior therapy.
Placebo Comparator: Placebo
Adolescents receive cognitive behavior therapy in combination with placebo.
Behavioral: Cognitive Behavior Therapy
Adolescents receive cognitive behavior therapy.
Other: Placebo

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
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

No publications provided

Responsible Party: Dr. Sayed Naqvi, M.D., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00658476     History of Changes
Other Study ID Numbers: 9407
Study First Received: April 8, 2008
Last Updated: March 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Adolescent Depression
Depression
Teenage Depression
Los Angeles

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014