Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia
NCT ID: NCT00585390
Last Updated: 2011-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
INTERVENTIONAL
2008-01-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Essential omega-3 fatty acid replacement
Omega-3 Fatty Acids
* Essential omega-3 fatty acid replacement therapy with Eicosapentaenoic acid at 3.2 grams
* Docosahexaenoic acid fish oil concentrate at 1.6 grams
EPA fish oil concentrate; DHA fish oil concentrate
3.2 grams for EPA 1.6 grams for DHA
Placebo
Olive oil placebo
Olive oil capsules, 8 capsules per day
Placebo
Olive oil capsule
Interventions
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Omega-3 Fatty Acids
* Essential omega-3 fatty acid replacement therapy with Eicosapentaenoic acid at 3.2 grams
* Docosahexaenoic acid fish oil concentrate at 1.6 grams
Olive oil placebo
Olive oil capsules, 8 capsules per day
EPA fish oil concentrate; DHA fish oil concentrate
3.2 grams for EPA 1.6 grams for DHA
Placebo
Olive oil capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
8 Years
25 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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University of Cincinnati
Principal Investigators
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Neil Richtand, MD
Role: PRINCIPAL_INVESTIGATOR
Unversity of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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Richtand #1
Identifier Type: -
Identifier Source: org_study_id
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