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The Role Of Omega-3 Fatty Acids In Adolescent Depression

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Vilma Gabbay, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00962598
First received: August 19, 2009
Last updated: April 17, 2017
Last verified: April 2017
August 19, 2009
April 17, 2017
January 2006
June 2013   (Final data collection date for primary outcome measure)
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).
Children's Depressive Rating Scale - Revised (CDRS-R) [ Time Frame: 10-week treatment phase ]
Complete list of historical versions of study NCT00962598 on ClinicalTrials.gov Archive Site
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.
Clinician's Global Improvement Scale (CGI) [ Time Frame: 10-week treatment phase ]
Not Provided
Not Provided
 
The Role Of Omega-3 Fatty Acids In Adolescent Depression
The Role Of Omega-3 Fatty Acids In Adolescent Depression
The purpose of this study is to examine the effects of a 10-week Omega-3 Fatty Acid treatment phase on brain chemistry of adolescents with major depressive disorder (MDD) using proton magnetic resonance imaging.

This study rests on a confluence of findings showing that: 1) Major depressive disorder (MDD), is a major public health concern that often emerges in adolescence; which entails 2) pathophysiological abnormalities in fronto-striatal structures resulting in death and atrophy of glia and neurons; 3) omega-3 fatty acids (FA) effects on brain function in adolescent MDD can be assessed by proton magnetic resonance spectroscopy (1H MRS); and, 4) it is critical that commonly used complementary and alternative medicines such as omega-3FA that have face validity be tested for their neurobiological effect in MDD.

Using 1H MRSI, this study examines the effects of Omega-3FA on striatal and anterior cingulate cortex (ACC) concentrations of the neurocellular biomarkers total choline (tCho), total creatine (tCr), and γ-aminobutyric acid (GABA, ACC only) in adolescent MDD. Hypotheses are: 1) relative to placebo, omega-3FA treatment will result in significant reductions of striatal and ACC tCho and tCr concentrations, and increased ACC GABA; 2: Regardless of treatment condition (placebo or Omega-3FA), MDD adolescents who are improved at the end of 10-week treatment will exhibit a significant decrease in striatal and ACC tCho and tCr concentrations, and increases in ACC GABA relative to unimproved adolescents.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Depressive Disorder, Major
  • Drug: Omega 3 Fatty Acids
    The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks.
    Other Name: Fish oil
  • Dietary Supplement: Corn oil
    The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
  • Placebo Comparator: Corn Oil
    The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
    Intervention: Dietary Supplement: Corn oil
  • Experimental: Omega-3 Fatty Acids
    The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
    Intervention: Drug: Omega 3 Fatty Acids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 12 to 19 years old (inclusive) of both sexes and all ethnic/racial groups.
  • DSM-IV-TR criteria for MDD
  • MDD Duration of at least 8 weeks and a severity score of at least 40 on the CDRS-R.
  • Age at first onset MDD of at least 12 years.
  • No significant medical or neurological disorder
  • For female subjects, negative pregnancy test at time of enrollment.
  • Female subjects who are sexually active and not using a method of birth control will be excluded. Use of hormonal contraceptives (such as prescribed "birth control pills" or a prescribed birth control implant) is not exclusionary.
  • Subjects must be able to swallow capsules.
  • A minimum IQ of 80 will be required.

Exclusion Criteria:

  • Current or Past DSM-IV-TR diagnoses of bipolar disorder, schizophrenia, psychosis, autism/pervasive developmental disorder (PDD), and Tourette's disorder (TD).
  • Current diagnosis of eating disorder, panic disorder, obsessive-compulsive disorder (OCD), post traumatic stress disorder (PTSD), conduct disorder, and substance related disorders other than nicotine.
  • Current suicidal ideation with intent or plan, or who may pose a danger to themselves.
  • Current antidepressant treatment will be excluded. Past antidepressant treatment will not be exclusionary, so long as patients are off antidepressant medication for 60 days prior to study entry. No individual will be advised to terminate ongoing treatment.
  • Certain short half-life medications, such as vitamins that contain unidentified ingredients, St. Johns Wort, S-adenosyl Methionine (SAM), clonidine, and some over-the-counter medications.
  • A minimum of 90 days off of treatment with long half life medications, such as neuroleptics, prior to study entry is required. Stimulant medication treatment for ADHD will not be exclusionary.
  • 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 study entry.
Sexes Eligible for Study: All
12 Years to 19 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00962598
GCO 12-1321
R21AT004576-01 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Vilma Gabbay, Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Vilma Gabbay, M.D. Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP