Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

NCT00585390 | Completed Phase 2

• 1 other identifier: Richtand #1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Fatty Acid Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Essential omega-3 fatty acid replacement

EXPERIMENTAL

Dietary Supplement: Omega-3 Fatty Acids; Dietary Supplement: EPA fish oil concentrate; DHA fish oil concentrate

Placebo

PLACEBO COMPARATOR

Other: Olive oil placebo; Drug: Placebo

Interventions

Omega-3 Fatty Acids DIETARY_SUPPLEMENT

* Essential omega-3 fatty acid replacement therapy with Eicosapentaenoic acid at 3.2 grams * Docosahexaenoic acid fish oil concentrate at 1.6 grams

Also known as: EPA, DHA

Essential omega-3 fatty acid replacement

Olive oil placebo OTHER

Olive oil capsules, 8 capsules per day

Also known as: Olive oil

Placebo

EPA fish oil concentrate; DHA fish oil concentrate DIETARY_SUPPLEMENT

3.2 grams for EPA 1.6 grams for DHA

Also known as: Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA)

Essential omega-3 fatty acid replacement

Placebo DRUG

Olive oil capsule

Also known as: Olive oil

Placebo

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0559, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Fatty Acids, Omega-3; Olive Oil; Eicosapentaenoic Acid; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Eicosanoids

Study Officials

• Neil Richtand, MD

  Unversity of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 3, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 2, 2011

Record last verified: 2011-07

Locations

US (1)