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Omega-3 Fatty Acids in Adolescent Depression

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ClinicalTrials.gov Identifier: NCT00312897
Recruitment Status : Completed
First Posted : April 11, 2006
Results First Posted : February 15, 2018
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Vilma Gabbay, Icahn School of Medicine at Mount Sinai

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Adolescent Depression Drug: Omega-3 Fatty Acids Drug: corn oil Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acids in Adolescent Depression
Study Start Date : December 2005
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: corn oil
as stated
Drug: corn oil
placebo comparator

Experimental: Omega 3 Fatty Acids
as stated
Drug: Omega-3 Fatty Acids
10 wk treatment period
Other Name: fish oil




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312897


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Center for Complementary and Integrative Health (NCCIH)
National Center for Research Resources (NCRR)
Investigators
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Principal Investigator: Vilma Gabbay, M.D. Icahn School of Medicine at Mount Sinai

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Responsible Party: Vilma Gabbay, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00312897     History of Changes
Other Study ID Numbers: GCO# 12-1321
R21AT002395-01A2 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2006    Key Record Dates
Results First Posted: February 15, 2018
Last Update Posted: April 19, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vilma Gabbay, Icahn School of Medicine at Mount Sinai:
Adolescents
Depression
Fish Oil
Omega-3 Fatty Acids
Psychiatry

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