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Completed

NCT Number: NCT00312897

Omega-3 Fatty Acids in Adolescent Depression

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.

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Key information

Conditions

Adolescent Depression Behavior Behavioral Symptoms Depression

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 Fatty acids

Drug

10 wk treatment period

Other names: fish oil

corn oil

Drug

placebo comparator

Primary outcomes

  1. Children's Depressive Rating Scale - Revised (CDRS-R)

    Time frame: 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 outcomes

  1. Clinician's Global Improvement Scale (CGI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Center for Research Resources (NCRR)

Registry information

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Apr 11, 2006
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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