Ethyl-EPA Treatment of Prodromal Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Yale University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Yale University
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00634361
First received: March 6, 2008
Last updated: March 12, 2008
Last verified: March 2008
| Tracking Information | |||||
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| First Received Date ICMJE | March 6, 2008 | ||||
| Last Updated Date | March 12, 2008 | ||||
| Start Date ICMJE | September 2001 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
conversion to psychosis [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00634361 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ethyl-EPA Treatment of Prodromal Patients | ||||
| Official Title ICMJE | Ethyl-EPA Treatment of Prodromal Patients | ||||
| Brief Summary | This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia prodrome. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Schizophrenia Prodrome | ||||
| Intervention ICMJE | Drug: ethyl-eicosapentaenoic acid
2 mg per day
Other Name: ethyl-EPA, an omega-3 fatty acid |
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| Study Arm (s) | Experimental: A
Intervention: Drug: ethyl-eicosapentaenoic acid |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 6 | ||||
| Estimated Completion Date | December 2009 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 14 Years to 35 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00634361 | ||||
| Other Study ID Numbers ICMJE | LA01.03.0011 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Scott W. Woods, M.D., Yale University School of Medicine | ||||
| Study Sponsor ICMJE | Yale University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Yale University | ||||
| Verification Date | March 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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