Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Fatty Acid Deficiency
• Intervention / Treatment: Dietary supplement: Omega-3 Fatty Acids; Dietary supplement: EPA fish oil concentrate; DHA fish oil concentrate; Other: Olive oil placebo; Drug: Placebo

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 Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0559
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Olive oil placebo; Olive oil capsules, 8 capsules per day; Other Names: Olive oil; Drug: Placebo; Olive oil capsule; Other Names: Olive oil
Experimental: Essential omega-3 fatty acid replacement	Dietary supplement: Omega-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; Other Names: DHA; EPA; Dietary supplement: EPA fish oil concentrate; DHA fish oil concentrate; 3.2 grams for EPA 1.6 grams for DHA; Other Names: Eicosapentaenoic acid (EPA); Docosahexaenoic acid (DHA)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Neil Richtand, MD, Unversity of Cincinnati

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: December 28, 2007
• First Posted (Estimate): January 3, 2008

Study Record Updates

• Last Update Posted (Estimate): August 2, 2011
• Last Update Submitted That Met QC Criteria: August 1, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: Richtand #1