The Role Of Omega-3 Fatty Acids In Adolescent Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vilma Gabbay, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00962598
First received: August 19, 2009
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Depressive Disorder, Major
Drug: Omega 3 Fatty Acids
Dietary Supplement: Corn oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role Of Omega-3 Fatty Acids In Adolescent Depression

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Children's Depressive Rating Scale - Revised (CDRS-R) [ Time Frame: 10-week treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician's Global Improvement scale (CGI) [ Time Frame: 10-week treatment phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Corn Oil
The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
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.
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962598

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York City, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Vilma Gabbay, M.D. Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Vilma Gabbay, Associate Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00962598     History of Changes
Other Study ID Numbers: GCO 12-1321, R21AT004576-01
Study First Received: August 19, 2009
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Adolescents
Major Depressive Disorder
Proton Magnetic Resonance Spectroscopy
Immune System Activation
Omega-3 Fatty Acids

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014