View Clinical Trial (Medical Research Study)
Early Detection and Intervention for the Prevention of Psychosis - NCT00531518-87131(Clinical Trial 704493)
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| City: |
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Albuquerque |
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State:
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NM |
| Zip Code: |
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87131 |
| Conditions: |
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Schizophrenia - Bipolar Disorder - Depression - Psychotic Disorders |
| Purpose: |
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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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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- Subjects in the age range of 12-25 and living in the experimental catchment area may
be enrolled in the EDIPP study based on meeting at least one of the inclusion
requirements AND none of the exclusion criteria;
- Screening process indicates symptoms equivalent to a minimum rating of '1' on at
least one positive symptom of psychosis;
- Screening process indicates a likely family history of first degree relative with
psychotic illness plus a deterioration in functioning equivalent to a 30% drop in
functioning score over the past year; OR
- Screening process indicates a likely history of schizotypal personality disorder plus
a deterioration in functioning equivalent to a 30% drop in functioning over the past
year.
Exclusion Criteria:
- Outside the age range of 12 to 25 years;
- History of IQ below 70 (based on school records, not tested at PIER);
- More than one month duration of psychosis (guided by the criteria of at least one 6
on the psychosis scales of the SIPS/SOPS);
- History of previous psychotic episode, whether or not treatment was received;
- Taken antipsychotic medication for more than 30 days at a therapeutic dose for
psychotic symptoms;
- Either the young person being screened for the study or both parents do not speak
proficient English;
- Female is pregnant at baseline (inquired on the screening interview); AND
- Subject is a prisoner. |
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| Study is available at: |
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University of New Mexico
Albuquerque, NM 87131
United States
Primary Contact:
Steven Adelsheim, M.D.
Email: sadelsheim@salud.unm.edu
Phone: 505-272-2223
Secondary Contact:
William R. McFarlane, M.D.
Email: mcfarw@mmc.org
Phone: 207-662-2091 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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