Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585390
• Other study ID #: Richtand #1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 28, 2007
• Last updated: August 1, 2011
• Start date: January 2008
• Est. completion date: November 2009

Study information

• Verified date: July 2011
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 25 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Acid Deficiency
• Schizophrenia

Intervention

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:
• Olive oil placebo
Olive oil capsules, 8 capsules per day

Dietary Supplement:
• EPA fish oil concentrate; DHA fish oil concentrate
3.2 grams for EPA 1.6 grams for DHA

Drug:
• Placebo
Olive oil capsule

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes