Schizophrenia ProdromePhase 2/3NCT00634361
Ethyl-EPA Treatment of Prodromal Patients
A Phase 2/3 study testing ethyl-eicosapentaenoic acid in people with Schizophrenia Prodrome, run by Yale University.
Trial summary
This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia prodrome. Read more about this study
- Who is it for?
- Ages 14 to 35 years
- Conditions the study is for
- Schizophrenia Prodrome
- What is being tested?
- ethyl-eicosapentaenoic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Aug 2005
- 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 14 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- meets criteria for schizophrenia prodrome
Who cannot join
- any lifetime antipsychotic treatment
About this study
This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia prodrome.
- Conditions
- Schizophrenia Prodrome
- Being tested
- ethyl-eicosapentaenoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethyl-eicosapentaenoic acidDrug
Also called ethyl-EPA, an omega-3 fatty acid
2 mg per day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: ethyl-eicosapentaenoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion to psychosis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startSep 2001
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia ProdromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott W Woods, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634361
- Sponsor's protocol ID
- LA01.03.0011
- Status last verified
- May 2014
- First submitted
- 6 Mar 2008
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethyl-EPA Treatment of Prodromal Patients
- ClinicalTrials.gov ID
- NCT00634361
- Acronym / sponsor ID
- LA01.03.0011
- Conditions
- Schizophrenia Prodrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2001
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 13 Mar 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.
This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia prodrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ethyl-eicosapentaenoic acid |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- meets criteria for schizophrenia prodrome
Key exclusion criteria (1 listed)
- any lifetime antipsychotic 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 |
|---|---|---|
| ethyl-eicosapentaenoic acidAlso: ethyl-EPA, an omega-3 fatty acid2 mg per day | Drug | A |
Primary outcome
conversion to psychosis
Time frame: one year
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 22 May 2014.
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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.
Scott W Woods, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ethyl-eicosapentaenoic acid in people with Schizophrenia Prodrome, run by Yale University.
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 1 inclusion and 1 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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
conversion to psychosis (time frame: one year). 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 22 May 2014.