Back to resultsOmega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia
Primary Purpose
Schizophrenia, Fatty Acid Deficiency
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acids
Olive oil placebo
EPA fish oil concentrate; DHA fish oil concentrate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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.
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Essential omega-3 fatty acid replacement
Placebo
Arm Description
Outcomes
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.
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.
Full Information
NCT ID
NCT00585390
First Posted
December 28, 2007
Last Updated
August 1, 2011
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT00585390
Brief Title
Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia
Official Title
Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Essential Fatty Acid Deficiency Replacement in Early Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Fatty Acid Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Essential omega-3 fatty acid replacement
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty Acids
Other Intervention Name(s)
EPA, DHA
Intervention Description
Essential omega-3 fatty acid replacement therapy with Eicosapentaenoic acid at 3.2 grams
Docosahexaenoic acid fish oil concentrate at 1.6 grams
Intervention Type
Other
Intervention Name(s)
Olive oil placebo
Other Intervention Name(s)
Olive oil
Intervention Description
Olive oil capsules, 8 capsules per day
Intervention Type
Dietary Supplement
Intervention Name(s)
EPA fish oil concentrate; DHA fish oil concentrate
Other Intervention Name(s)
Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA)
Intervention Description
3.2 grams for EPA 1.6 grams for DHA
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Olive oil
Intervention Description
Olive oil capsule
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Richtand, MD
Organizational Affiliation
Unversity of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
12. IPD Sharing Statement
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Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia
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