Omega-3 Fatty Acids in Adolescent Depression

Phase 2

Completed

Brief Summary: Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1) change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end of 10-week treatment.

Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at the end of treatment compared to placebo.

Detailed Description: Title: Omega-3 Fatty Acids in Adolescents with Depression

NOTE: No individual will be advised to terminate ongoing treatment. If adolescents have been in psychotherapy prior to their entry in the study, they will be allowed to continue with the treatment. However, psychotherapy cannot be initiated at the time of entry into the study.

Aim: To provide preliminary clinical data about the efficacy of omega-3FA (derived from fish oil) in the treatment of adolescent MDD. A NCCAM/NIH-funded study.

Summary: Informed consent will be obtained from parent/guardian and assent obtained from participant. Interested participants will have a free diagnostic evaluation by study psychiatrist to determine eligibility. Routine blood tests and a urine pregnancy test will be obtained. Eligible participants will be randomized to receive either omega-3FA or matching placebo (corn oil) for 10 weeks. Patients will be seen weekly throughout the trial. Dosage will be titrated based on clinical response and side effects. At end of double-blind phase, participants will be referred to a clinician who will be informed of subjects' treatment. Depending on treatment received during double-blind phase, post-study treatment options will include treatment with omega-3 fatty acids or an SSRI.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Current or past DSM-IV-TR bipolar, schizophrenia, psychosis, pervasive developmental disorder (PDD), and Tourette's disorder.
Current diagnosis of eating, panic, conduct, obsessive compulsive, post traumatic stress, and/or substance-related disorders (other than nicotine).
Adolescents who present with current suicidal ideation with intent or plan, or who may pose a danger to themselves.
Current antidepressant treatment, or taken within 60 days prior to enrollment
Neuroleptics taken within 90 days prior to enrollment

Arm && Interventions

Group	Intervention	Description
Omega 3 Fatty Acids	Omega-3 Fatty Acids	as stated
corn oil	corn oil	as stated

Primary Outcome Measures

Name	Time	Method
Children's Depressive Rating Scale - Revised (CDRS-R)	baseline and 10-weeks	It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms).

Secondary Outcome Measures

Name	Time	Method
Clinician's Global Improvement Scale (CGI)	baseline and 10-week treatment phase	a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.