Trial Information

Summary: PUFA Augmentation for Treatment of Adolescent Unipolar Major Depression

Depression is a major public health problem. Although pharmacotherapy is the mainstay of treatment for depression, it is not an optimal treatment. Recently, significant concerns have been raised about the use of antidepressant medications inducing suicidality in adolescent patients and incurring harm in the treatment within this age group. Recent research suggests that polyunsaturated fatty acids (PUFAs), which are natural supplements and sometimes referred to as Omega-3 fatty acids, may alleviate the symptoms of depression. The purpose of this research study is to investigate the efficacy and safety of these natural supplements (PUFAs) for treatment of depression in adolescents.

This double-blind, randomized study will last for 8 weeks not including screening and baseline visits. All participants will receive cognitive behavioral therapy (CBT – a type of counseling) and in addition will be randomized into one of two groups. One group will receive the study medication (PUFA) and the other group will receive a placebo. In addition to therapy sessions and administration of study medication, study visits may include physicals, urine samples, blood draws, and interviews and questionnaires concerning side effects and mood. A study doctor will follow the progress of all participants in the research study.

Patient Inclusion Criteria:

- 13-21 years of age
- Diagnosed with depression by study staff

Patient Exclusion Criteria:

- Suicidal ideation, active planning and/or recent suicide attempt
- Severe psychotic symptoms
- History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, or autism
- Use of psychotropic medication(s) within 2 weeks prior to study entry (8 weeks for fluoxetine and MAOIs)
- Use of alcohol and/or drugs within 2 weeks prior to study entry
- Pregnant and/or lactating females
- History of seizure or other neurological disorders
- Dermatological conditions (only if treated with medications e.g. Accutane)
- Unstable cardiac, pulmonary. endocrine, or renal disorders
- Non-English speaker

If you would like to learn more about participating in this study, please send an e-mail message using the form below.