Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00585390
First received: December 28, 2007
Last updated: August 1, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Schizophrenia
Fatty Acid Deficiency
Dietary Supplement: Omega-3 Fatty Acids
Other: Olive oil placebo
Dietary Supplement: EPA fish oil concentrate; DHA fish oil concentrate
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Essential Fatty Acid Deficiency Replacement in Early Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • EPA
  • DHA
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)
Placebo Comparator: Placebo Other: Olive oil placebo
Olive oil capsules, 8 capsules per day
Other Name: Olive oil
Drug: Placebo
Olive oil capsule
Other Name: Olive oil

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.

  Eligibility

Ages Eligible for Study:   8 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585390

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Neil Richtand, MD Unversity of Cincinnati
  More Information

No publications provided

Responsible Party: Neil Richtand, MD / Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00585390     History of Changes
Other Study ID Numbers: Richtand #1
Study First Received: December 28, 2007
Last Updated: August 1, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014