SchizophreniaPhase 2/3NCT00585390
Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia
A Phase 2/3 study testing Omega-3 Fatty Acids and EPA fish oil concentrate; DHA fish oil concentrate in people with Schizophrenia and Fatty Acid Deficiency, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to find out what effects (good and bad) that omega-3 fatty acids has on schizophrenia. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Schizophrenia, Fatty Acid Deficiency
- What is being tested?
- Omega-3 Fatty Acids and EPA fish oil concentrate; DHA fish oil concentrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Nov 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati
Cincinnati, Ohio, 45267-0559
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Essential Fatty Acid Deficiency Replacement in Early Schizophrenia
The purpose of this research study is to find out what effects (good and bad) that omega-3 fatty acids has on schizophrenia.
Read the 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.
- Conditions
- Schizophrenia, Fatty Acid Deficiency
- Being tested
- Omega-3 Fatty Acids, Olive oil placebo, EPA fish oil concentrate; DHA fish oil concentrate, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidsDietary supplement
Also called EPA, DHA
- Essential omega-3 fatty acid replacement therapy with Eicosapentaenoic acid at 3.2 grams
- Docosahexaenoic acid fish oil concentrate at 1.6 grams
Olive oil placeboOther
Also called Olive oil
Olive oil capsules, 8 capsules per day
EPA fish oil concentrate; DHA fish oil concentrateDietary supplement
Also called Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA)
3.2 grams for EPA 1.6 grams for DHA
PlaceboDrug
Also called Olive oil
Olive oil capsule
| Study group | Role | What they receive |
|---|---|---|
| Essential omega-3 fatty acid replacement | Experimental | Not described Receives: Dietary Supplement: Omega-3 Fatty Acids; Dietary Supplement: EPA fish oil concentrate; DHA fish oil concentrate |
| Placebo | Placebo comparator | Not described Receives: Other: Olive oil placebo; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine positive symptom treatment response in omega-3 fatty acid deficient first-episode schizophrenia patients augmented with omega-3 fatty acid supplementation vs. placebo.
Measured: 12 months
Secondary outcomes (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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Investigators
- Neil Richtand, MD, Principal investigator, Unversity of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585390
- Sponsor's protocol ID
- Richtand #1
- Status last verified
- Jul 2011
- First submitted
- 28 Dec 2007
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Essential Fatty Acid Deficiency Replacement in Early Schizophrenia
- ClinicalTrials.gov ID
- NCT00585390
- Acronym / sponsor ID
- Richtand #1
- Conditions
- Schizophrenia, Fatty Acid Deficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential omega-3 fatty acid replacement | Experimental | Dietary Supplement: Omega-3 Fatty Acids, Dietary Supplement: EPA fish oil concentrate; DHA fish oil concentrate |
| Placebo | Placebo comparator | Other: Olive oil placebo, Drug: Placebo |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty AcidsAlso: EPA, DHA* Essential omega-3 fatty acid replacement therapy with Eicosapentaenoic acid at 3.2 grams * Docosahexaenoic acid fish oil concentrate at 1.6 grams | Dietary supplement | Essential omega-3 fatty acid replacement |
| Olive oil placeboAlso: Olive oilOlive oil capsules, 8 capsules per day | Other | Placebo |
| EPA fish oil concentrate; DHA fish oil concentrateAlso: Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA)3.2 grams for EPA 1.6 grams for DHA | Dietary supplement | Essential omega-3 fatty acid replacement |
| PlaceboAlso: Olive oilOlive oil capsule | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Richtand, MD principal investigator
Unversity of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omega-3 Fatty Acids and EPA fish oil concentrate; DHA fish oil concentrate in people with Schizophrenia and Fatty Acid Deficiency, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011.