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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 18, 2007 | ||||||||
| Last Updated Date | May 6, 2009 | ||||||||
| Start Date ICMJE | October 2007 | ||||||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Conversion to psychosis [ Time Frame: two years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Conversion to psychosis [ Time Frame: two years ] | ||||||||
| Change History | Complete list of historical versions of study NCT00531518 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Social and occupational functioning [ Time Frame: two years ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Social and occupational functioning [ Time Frame: two years ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Early Detection and Intervention for the Prevention of Psychosis, A Multi-Site Study | ||||||||
| Official Title ICMJE | Early Detection and Intervention for the Prevention of Psychosis Project | ||||||||
| Brief Summary | EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at six sites across the United States. The hypothesis is that very early identification and intervention will be effective in delaying or preventing onset of psychosis and improving social and occupational functioning. |
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| Detailed Description | The study is structured as a cutoff, regression discontinuity design, in which lower risk-for-psychosis participants will not be treated by protocol but followed up for two years. Those at higher risk will be treated with anti-psychotic, antidepressant and mood stabilizing medications by symptom indications, and systematically provided psychoeducational multifamily group treatment, supported education and employment, and intensive clinical case management, using key elements of Assertive Community Treatment. Both arms of the study will be followed for two years and assessed at 6, 12, and 24 months. Outcome measures include rates of conversion to psychosis, relapse of psychosis, development of psychotic disorder diagnoses, levels of positive, negative and general symptoms, social and vocational functioning, family functioning, and neurocognitive functioning. The six sites include Sacramento, California; Salem Oregon; and surrounding counties, Ypsilanti and Washtenaw County, Michigan; Portland, Maine; Albuquerque, New Mexico and Glen Oaks, New York. In addition to symptomatic and functional outcomes, impact on incidence of psychotic disorders, including schizophrenia, will be assessed, as will cost-benefit effects. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 900 | ||||||||
| Estimated Completion Date | April 2011 | ||||||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 12 Years to 25 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00531518 | ||||||||
| Responsible Party | James Donovan, Assoc V.P. Medical Affairs, Maine Medical Center | ||||||||
| Study ID Numbers ICMJE | 58920, RWJF #58920 | ||||||||
| Study Sponsor ICMJE | Maine Medical Center | ||||||||
| Collaborators ICMJE | Robert Wood Johnson Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | Maine Medical Center | ||||||||
| Verification Date | May 2009 | ||||||||
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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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