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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014