Omega-3 Fatty Acids for Treatment of Depression in Adolescents

Study Overview
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Brief Summary
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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.

Official Title
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Treating Adolescent Depression With Fish Oils

Conditions
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Depression

Intervention / Treatment
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* Dietary Supplement: Fish Oil
* Behavioral: Cognitive Behavior Therapy
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 Fatty Acids<br>Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements. | Dietary Supplement: Fish Oil<br>* Omega-3 fatty acid supplements.<br>Behavioral: Cognitive Behavior Therapy<br>* Adolescents receive cognitive behavior therapy.<br>|
| Placebo Comparator: Placebo<br>Adolescents receive cognitive behavior therapy in combination with placebo. | Behavioral: Cognitive Behavior Therapy<br>* Adolescents receive cognitive behavior therapy.<br>Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Depression Inventory - CDI |  | 8 times for an average of 8 weeks | 
| Hamilton Depression Rating Scale |  | 8 times for an average of 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent Depression, Depression, Teenage Depression, Los Angeles