Clinical trial NCT00658476: Omega-3 Fatty Acids for Treatment of Depression in Adolescents
Official title: Treating Adolescent Depression With Fish Oils
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Adolescent Depression
Depression
Teenage Depression
Los Angeles
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2008-04-15
Enrollment: 4
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Child Depression Inventory - CDI
timeFrame: 8 times for an average of 8 weeks
measure: Hamilton Depression Rating Scale
timeFrame: 8 times for an average of 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Sayed Naqvi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: