Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
The Inflammation Research Foundation
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00511810
First received: August 3, 2007
Last updated: March 29, 2011
Last verified: March 2011
  Purpose

The purpose of the research is to study the effects of increasing dietary omega-3 fatty acid intake symptoms of depression, and brain structure, function and chemistry in adolescent depressed patients 12 to18 year old that are currently not responding to their prescribed antidepressant medication.


Condition Intervention Phase
Major Depressive Disorder
Neuroimaging
Dietary Supplement: capsule Omega-3 Fatty Acids 2.4g/day (4 capsules/day)
Dietary Supplement: liquid omega-3 fatty acids 15g/day (2 Tablespoons/day)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Omega-3 Fatty Acids as a Treatment-adjunct in Adolescent Patients With Major Depressive Disorder Exhibiting Partial Response to SSRI Medications: An Open-label Neuroimaging Trial

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • To evaluate the effects of EPA+DHA treatment on depression ratings and prefrontal cortex blood flow at rest and during performance of a sustained attention task (fMRI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Capsule omega-3 fatty acids 2.4g/day (4 capsules/day) or liquid omega-3 fatty acids 15g/day (2 Tablespoons/day).
Dietary Supplement: capsule Omega-3 Fatty Acids 2.4g/day (4 capsules/day)
Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)
Other Name: 2.4g/day Omega 3
Dietary Supplement: liquid omega-3 fatty acids 15g/day (2 Tablespoons/day)
15g/day Omega 3 liquid
Other Name: 15g/day Omega 3

Detailed Description:

This study is a 10-week open-label EPA+DHA treatment trial in adolescent (aged 12-18 years) patients with major depressive disorder exhibiting partial response to SSRI medications. During the screening visit, informed consent/assent, review of entrance criteria, demographic data, medical evaluation, physical examination, family psychiatric history, blood drawn (2 ml, to determine fatty acid composition, CBC, and TSH), Crovitz test for handedness, dietary DHA questioner administered, breastfeeding history, and patient medication history (including current medications) will be obtained. A semi-structured diagnostic tool, the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) will be used to confirm diagnosis, and depression symptom severity will be determined with the Children Depression Rating Scale-Revised (CDRS-R). During the baseline visit, entrance criteria will be re-reviewed, vital signs (height, weight, temperature, blood pressure, heart rate) determined, a cognitive task, the California Verbal Learning Test (CVLT), and the CDRS-R, Side-Effects Form for Children and Adolescents (SEFCA), and the Young Mania Rating Scale (YMRS) will be administered. Urine pregnancy and toxicology screens will also be administered. Subjects will then participate in fMRI scan during which they will perform an attention task (Identical Pairs Continuous Performance Test, CPT-IP). At the conclusion of the baseline visit, study drug (1 week supply) will be dispensed. Parents/patients will participate in weekly visits to evaluate treatment response (CDRS-R), adverse effects (SEFCA), obtain vital signs, and dispense study drug. On every second visit, the YMRS will also be administered. At 10-weeks (Final visit), the CDRS-R, YMRS, SEFCA, and CVLT will be re-administered, blood drawn (2 ml), vital signs determined, and a post-treatment fMRI scan performed. Urine pregnancy and toxicology screens will also be administered. Drs. Melissa Delbello, M.D. and Jayasree Nandagopal, M.D., pediatric/adolescent psychiatrists, will serve as the medically responsible physicians on this trial, and will perform the psychiatric interviews and patient surveillance. If a patient's mood symptoms worsen over the course of the trial (defined as 30% worsening relative to baseline on two consecutive visits using the CDRS-R), they will be withdrawn from the study and their treating physician notified.

  Eligibility

Ages Eligible for Study:   8 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criterion:

  • Between the ages of 8-25 years.
  • Diagnosis of MDD and not exhibited symptom remission CDRS-R (> 28 but < 40) despite being administered a standard therapeutic dose of an SSRI continuously for a minimum of 6 weeks.
  • Ability and willingness to provide assent and informed, written consent from at least one biological parent.
  • Present with biological parent or legal guardian.
  • Willingness to maintain current dietary habits.
  • Permission from treating physician
  • Able to perform fMRI/MRS.

Exclusion Criterion:

  • Inability or unwillingness to provide consent.
  • Antecedent or concurrent serious medical illness.
  • Clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease.
  • History of seizures, excluding febrile seizures in childhood.
  • Patients requiring treatment with any drug which might obscure the action of the study treatment.
  • Female patients who are either pregnant or lactating.
  • Clinically significant laboratory abnormalities in the last year on CBC or TSH tests.
  • Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within the past 6 months, or a baseline CDRS-R suicide score of >3).
  • Hospitalized within the last 3 months
  • Greater than 1 year outside appropriate age/grade level
  • Pacemaker
  • Cerebral aneurysm clip
  • Cochlear implant
  • Metal fragments lodged within the eye or braces
  • Claustrophobia
  • Necessity of sedation (no sedation will be given).
  • History of loss of consciousness > 10 minutes in duration
  • Allergy to seafood.
  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: NCT00511810

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
The Inflammation Research Foundation
Investigators
Principal Investigator: Robert McNamara, PhD University of Cincinnati
  More Information

No publications provided

Responsible Party: Robert McNamara, PhD / Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00511810     History of Changes
Other Study ID Numbers: McNamara Omega3 MDD
Study First Received: August 3, 2007
Last Updated: March 29, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014