Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia; Fatty Acid Deficiency
• Interventions: Dietary Supplement: Omega-3 Fatty Acids; Other: Olive oil placebo; Dietary Supplement: EPA fish oil concentrate; DHA fish oil concentrate; Drug: Placebo

• Registration Number: NCT00585390
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2007-12-28
• Study Start: 2008-01
• Study First Posted: 2008-01-03
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2011-07
• Last Update Submitted: 2011-08-01
• Last Update Posted: 2011-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Essential omega-3 fatty acid replacement	Omega-3 Fatty Acids	-
Essential omega-3 fatty acid replacement	EPA fish oil concentrate; DHA fish oil concentrate	-
Placebo	Olive oil placebo	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States