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Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

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ClinicalTrials.gov Identifier: NCT00585390
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : August 2, 2011
Sponsor:
Information provided by:
University of Cincinnati

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.

Condition or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Essential Fatty Acid Deficiency Replacement in Early Schizophrenia
Study Start Date : January 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Neil Richtand, MD / Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00585390     History of Changes
Other Study ID Numbers: Richtand #1
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders