Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

University of Cincinnati

Status and phase

Completed

Phase 3

Phase 2

Conditions

Schizophrenia

Fatty Acid Deficiency

Treatments

Drug: Placebo

Dietary Supplement: Omega-3 Fatty Acids

Dietary Supplement: EPA fish oil concentrate; DHA fish oil concentrate

Other: Olive oil placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00585390

Richtand #1

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

8 to 25 years old

Volunteers

No Healthy Volunteers

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.