Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

Study Overview
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Brief Summary
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The purpose of this research study is to find out what effects (good and bad) that omega-3 fatty acids has on schizophrenia.

Detailed Description
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The two aims of the study test the hypotheses that correcting omega-3 fatty acid deficiency in the early stages of schizophrenia improves positive symptom treatment response, negative symptom treatment response, and cognition symptom response.

Official Title
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Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Essential Fatty Acid Deficiency Replacement in Early Schizophrenia

Conditions
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Schizophrenia, Fatty Acid Deficiency

Intervention / Treatment
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* Dietary Supplement: Omega-3 Fatty Acids
* Other: Olive oil placebo
* Dietary Supplement: EPA fish oil concentrate; DHA fish oil concentrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Essential omega-3 fatty acid replacement<br> | Dietary Supplement: Omega-3 Fatty Acids<br>* Essential omega-3 fatty acid replacement therapy with Eicosapentaenoic acid at 3.2 grams Docosahexaenoic acid fish oil concentrate at 1.6 grams<br>* Other names: DHA;Dietary Supplement: EPA fish oil concentrate; DHA fish oil concentrate<br>* 3.2 grams for EPA 1.6 grams for DHA<br>* Other names: Docosahexaenoic acid (DHA);|
| Placebo Comparator: Placebo<br> | Other: Olive oil placebo<br>* Olive oil capsules, 8 capsules per day<br>* Other names: Olive oil;Drug: Placebo<br>* Olive oil capsule<br>* Other names: Olive oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine positive symptom treatment response in omega-3 fatty acid deficient first-episode schizophrenia patients augmented with omega-3 fatty acid supplementation vs. placebo. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine negative and cognitive symptom treatment response in omega-3 fatty acid deficient first-episode schizophrenia patients augmented with omega-3 supplementation vs. placebo. |  | 12 months |