Major Depressive Disorder Clinical Trial
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
Verified date | December 2014 |
Source | University of Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective of the study was to determine the effects of 10-week adjunctive
supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity
and biochemistry in adolescents with MDD.
The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently
increase prefrontal cortical functional activation during sustained attention and increase
regional biochemical indices of cortical metabolism and integrity concentrations in
association with reductions in depressive symptoms.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 18 Years |
Eligibility |
Inclusion Criterion: - Between the ages of 12-18 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati | The Inflammation Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mood Symptoms Ratings | Depression symptom severity was determined with the Children's Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of <28. (The total score is the sum of the ratings on each of the 17 items.) | 10 weeks | No |
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