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

Cedars-Sinai Medical Center

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Dietary Supplement: Fish Oil; Behavioral: Cognitive Behavior Therapy; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00658476

9407

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups, including a placebo group

Omega-3 Fatty Acids

Experimental group

Description:

Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements.

Treatment:

Behavioral: Cognitive Behavior Therapy

Dietary Supplement: Fish Oil

Placebo

Placebo Comparator group

Description:

Adolescents receive cognitive behavior therapy in combination with placebo.

Treatment:

Behavioral: Cognitive Behavior Therapy

Other: Placebo