Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Schizophrenia, Fatty Acid Deficiency

In brief

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

Key facts

Study ID

NCT00585390

Run by

University of Cincinnati

People needed

0

Starts

2008-01-01

Expected to finish

2009-11-01

Last updated by the study team

2011-08-02

Who can join

Age: 8 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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