Fatty Acid Deficiency, Schizophrenia
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTOmega-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
OTHEROlive oil placebo
Olive oil capsules, 8 capsules per day
DIETARY_SUPPLEMENTEPA fish oil concentrate; DHA fish oil concentrate
3.2 grams for EPA 1.6 grams for DHA
DRUGPlacebo
Olive oil capsule
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed