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

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ClinicalTrials.gov Identifier: NCT00658476
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : March 27, 2012
Information provided by:

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Adolescent Depression With Fish Oils
Study Start Date : November 2006
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658476

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
Principal Investigator: Sayed Naqvi, M.D. Cedars-Sinai Medical Center
More Information

Responsible Party: Dr. Sayed Naqvi, M.D., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00658476     History of Changes
Other Study ID Numbers: 9407
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012

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

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