Status:
COMPLETED
Omega-3 Fatty Acids for Treatment of Depression in Adolescents
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Depression
Eligibility:
All Genders
13-21 years
Phase:
PHASE3
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. Bec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00658476
Start Date
November 1 2006
End Date
April 1 2009
Last Update
March 27 2012
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048