Skip to main content
OpenTrials
Completed

NCT Number: NCT00585390

Omega-3 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267-0559, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: EPA, DHA

Olive oil placebo

Other

Olive oil capsules, 8 capsules per day

Other names: Olive oil

EPA fish oil concentrate; DHA fish oil concentrate

Dietary Supplement

3.2 grams for EPA 1.6 grams for DHA

Other names: Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA)

Placebo

Drug

Olive oil capsule

Other names: Olive oil

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.

    Time frame: 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.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 3, 2008
Registry last updated
Aug 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.