Clinical trial NCT00531518: Early Detection and Intervention for the Prevention of Psychosis
Official title: Early Detection and Intervention for the Prevention of Psychosis Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Depression
Psychotic Disorders
Keywords: Schizophrenia
Bipolar disorder
Psychosis
Prodromal psychosis
Family psychoeducation
Supported education
Supported employment
Ulra-high-risk for psychosis
Major depression
Bipolar disorder, with psychotic features
Major depression, with psychotic features
Attenuated, prodromal psychotic symptoms
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2007-09-19
Enrollment: 292
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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 intelligence quotient (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 Positive Symptom sub-scale of the Scale of Positive Symptoms (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.

Primary outcomes:
measure: Psychotic Symptoms
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis, Imaging Research Center
state: California
city: Portland
country: United States
facility: Portland Identification and Early Referral Program
state: Maine
city: Ann Arbor
country: United States
facility: Washtenaw County
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Glen Oaks
country: United States
facility: Zucker Hillside Hosptial
state: New York
city: Salem
country: United States
facility: Mid-Valley Behavioral Care Network
state: Oregon
Study officials:
affiliation: MaineHealth
name: William R. McFarlane, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lynch S, McFarlane WR, Joly B, Adelsheim S, Auther A, Cornblatt BA, Migliorati M, Ragland JD, Sale T, Spring E, Calkins R, Carter CS, Jaynes R, Taylor SF, Downing D. Early Detection, Intervention and Prevention of Psychosis Program: Community Outreach and Early Identification at Six U.S. Sites. Psychiatr Serv. 2016 May 1;67(5):510-6. doi: 10.1176/appi.ps.201300236. Epub 2016 Jan 14.
citation: McFarlane WR, Levin B, Travis L, Lucas FL, Lynch S, Verdi M, Williams D, Adelsheim S, Calkins R, Carter CS, Cornblatt B, Taylor SF, Auther AM, McFarland B, Melton R, Migliorati M, Niendam T, Ragland JD, Sale T, Salvador M, Spring E. Clinical and functional outcomes after 2 years in the early detection and intervention for the prevention of psychosis multisite effectiveness trial. Schizophr Bull. 2015 Jan;41(1):30-43. doi: 10.1093/schbul/sbu108. Epub 2014 Jul 26.