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The Role Of Omega-3 Fatty Acids In Adolescent Depression

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ClinicalTrials.gov Identifier: NCT00962598
Recruitment Status : Completed
First Posted : August 20, 2009
Results First Posted : May 24, 2017
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Vilma Gabbay, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE August 19, 2009
First Posted Date  ICMJE August 20, 2009
Results First Submitted Date  ICMJE April 17, 2017
Results First Posted Date  ICMJE May 24, 2017
Last Update Posted Date April 24, 2018
Study Start Date  ICMJE January 2006
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • ACC Glx/Water [ Time Frame: baseline and 10-weeks ]
    The data reflects the ratio of Glutamine-Glutamate and water in the brain (ratio divided by 10000 for analysis purposes). Glutamate is a precursor to Glutamine, an amino acid which functions as an excitatory neurotransmitter in the human brain.
  • ACC GABA/Water [ Time Frame: baseline and 10-weeks ]
    The ratio of gamma-Aminobutyric acid (GABA) and water in the brain (ratio divided by 10000 for analysis purposes), that was observed in MR Spectroscopy. GABA, an amino acid produced by cells of the central nervous system, is an inhibitory neurotransmitter, prominent in the human brain.
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
Children's Depressive Rating Scale - Revised (CDRS-R) [ Time Frame: 10-week treatment phase ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
Clinician's Global Improvement scale (CGI) [ Time Frame: 10-week treatment phase ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role Of Omega-3 Fatty Acids In Adolescent Depression
Official Title  ICMJE The Role Of Omega-3 Fatty Acids In Adolescent Depression
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Gabbay V, Freed RD, Alonso CM, Senger S, Stadterman J, Davison BA, Klein RG. A Double-Blind Placebo-Controlled Trial of Omega-3 Fatty Acids as a Monotherapy for Adolescent Depression. J Clin Psychiatry. 2018 Jun 26;79(4). pii: 17m11596. doi: 10.4088/JCP.17m11596.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2009)
40
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00962598
Other Study ID Numbers  ICMJE GCO 12-1321
R21AT004576-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vilma Gabbay, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Vilma Gabbay, M.D. Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2018

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