Omega-3 Fatty Acids in Adolescent Depression

Mount Sinai Health System

Status and phase

Completed

Phase 2

Conditions

Adolescent Depression

Treatments

Drug: Omega-3 Fatty Acids

Drug: corn oil

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00312897

R21AT002395-01A2 (U.S. NIH Grant/Contract)

GCO# 12-1321

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

All

Ages

12 to 19 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: 12-19
Depressed with DSM-IV diagnosis of MDD
Duration of depressive episode greater than 6 weeks

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