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The Role Of Omega-3 Fatty Acids In Adolescent Depression

Primary Purpose

Depressive Disorder, Major

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Omega 3 Fatty Acids

Corn oil

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Adolescents, Major Depressive Disorder, Proton Magnetic Resonance Spectroscopy, Immune System Activation, Omega-3 Fatty Acids

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Corn Oil

Omega-3 Fatty Acids

Arm Description

The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.

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.

Outcomes

Primary Outcome Measures

ACC Glx/Water

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00962598

First Posted

August 19, 2009

Last Updated

April 20, 2018

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00962598

Brief Title

The Role Of Omega-3 Fatty Acids In Adolescent Depression

Official Title

The Role Of Omega-3 Fatty Acids In Adolescent Depression

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major

Keywords

Adolescents, Major Depressive Disorder, Proton Magnetic Resonance Spectroscopy, Immune System Activation, Omega-3 Fatty Acids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Corn Oil

Arm Type

Placebo Comparator

Arm Description

The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.

Arm Title

Omega-3 Fatty Acids

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

Omega 3 Fatty Acids

Other Intervention Name(s)

Fish oil

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Corn oil

Intervention Description

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.

Primary Outcome Measure Information:

Title

ACC Glx/Water

Description

Time Frame

baseline and 10-weeks

Title

ACC GABA/Water

Description

Time Frame

baseline and 10-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vilma Gabbay, M.D.

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29985566

Citation

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):17m11596. doi: 10.4088/JCP.17m11596.

Results Reference

derived

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The Role Of Omega-3 Fatty Acids In Adolescent Depression

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