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Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia
This study is currently recruiting participants.
Verified by University of Cincinnati, October 2008
Sponsored by: University of Cincinnati
Information provided by: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00585390
  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
Phase II
Phase III

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title: Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Essential Fatty Acid Deficiency Replacement in Early Schizophrenia

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 ]

Estimated Enrollment: 80
Study Start Date: January 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Dietary Supplement: Omega-3 Fatty Acids
3.2 g/day EPA, 1.6 g/day DHA, 8 capsules a day
2: Placebo Comparator Other: Olive oil placebo
placebo capsules, 8 capsules per day

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects will meet DSM-IV diagnostic criteria for schizophreniform disorder or schizophrenia, with psychotic symptoms persisting at least four weeks in total, and not more than 24 months.
  2. Subjects will be between 15 and 40 years of age, inclusive.
  3. Subjects will be able to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.
  4. Fasting red blood cell fatty acid composition omega-3 index of less than or equal to 1.5 %. That corresponds to a 60% deficit relative to normal controls (Evans et al., 2003;Reddy et al., 2004;Khan et al., 2002). Based on our data, a comparable 65% RBC DHA composition deficit alters rodent behavior in an animal model of psychosis (McNamara et al., submitted).
  5. Subjects will be able to participate in treatment for their illness, including willingness to receive antipsychotic medication prescribed by their treating physician as part of their treatment plan.

Exclusion Criteria:

  1. Greater than a four month total previous history of antipsychotic drug treatment;
  2. Con¬firmed or suspected drug-induced psychosis;
  3. Serious, unstable medical illness;
  4. Underlying medical condition which could cause psychotic symptoms;
  5. Known history of seizure disorder, or a clinically significant head injury (prolonged loss of consciousness, neurological sequelae, or demonstrated structural brain injury);
  6. Mental retardation;
  7. Known hypersensitivity to study medication;
  8. Substance dependence within the previous 6 months;
  9. Current symptoms which present serious risk of danger to self or others.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585390

Contacts
Contact: Neil Richtand, MD 513-558-6657 neil.richtand@uc.edu

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267-0559
Contact: Neil Richtand, MD     513-558-6657     neil.richtand@uc.edu    
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Neil Richtand, MD Unversity of Cincinnati
  More Information

Responsible Party: University of Cincinnati ( Neil Richtand, MD / Professor )
Study ID Numbers: Richtand #1
Study First Received: December 28, 2007
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00585390  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009