Early Detection and Intervention for the Prevention of Psychosis, A Multisite Study

Condition(s) targeted: Schizophrenia; Bipolar Disorder; Depression; Psychotic Disorders

Intervention: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine (Drug); Psychoeducational multifamily group treatment (Behavioral); Supported employment and education (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Maine Medical Center

Official(s) and/or principal investigator(s):
William R. McFarlane, M.D., Principal Investigator, Affiliation: Maine Medical Center

Overall contact:
William R. McFarlane, M.D., Phone: 207-662-2091, Email: mcfarw@mmc.org

EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at five 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.

Official title: Early Detection and Intervention for the Prevention of Psychosis Project

Study design: Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Conversion to psychosis

Secondary outcome: 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 five sites will include Sacramento, California; Salem Oregon; and surrounding counties, Ypsilanti and Washtenaw County, Michigan; Portland, Maine; 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.

Minimum age: 12 Years. Maximum age: 25 Years. Gender(s): Both.

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.

Inclusion 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:

Subjects are excluded if:

- 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.

William R. McFarlane, M.D., Phone: 207-662-2091, Email: mcfarw@mmc.org

University of California-Davis, Imaging Research Center, Sacramento, California 95817, United States; Recruiting
Cameron Carter, M.D., Phone: 916-734-3230, Email: cameron.carter@ucdmc.ucdavis.edu
Daniel Ragland, Ph.D., Phone: 916.734.5802, Email: jdragland@ucdavis.edu
Cameron Carter, M.D., Principal Investigator

Portland Identification and Early Referral Program, Portland, Maine 04102, United States; Recruiting
William McFarlane, M.D., Phone: 207-662-2091, Email: mcfarw@mmc.org
William L. Cook, Ph.D., Phone: 207-662-2091, Email: cookw@mmc.org
William R. McFarlane, M.D., Principal Investigator

Washtenaw County, Ann Arbor, Michigan 48108, United States; Recruiting
Karen Milner, M.D., Phone: 734-936-5879, Email: kmilner@umich.edu
Elizabeth Spring, R.N., Phone: 734.368.8794, Email: springe@washtenaw.org
Karen Milner, M.D., Principal Investigator

Zucker Hillside Hosptial, Glen Oaks, New York 11004, United States; Recruiting
Barbara Cornblatt, Ph.D., Phone: 718-470-8133, Email: cornblat@lij.edu
Christopher Smith, Ph.D, Phone: 718.470.8286, Email: csmith@lij.edu
Barbara Cornblatt, Ph.D., Principal Investigator

Mid-Valley Behavioral Care Network, Salem, Oregon 97301, United States; Recruiting
Rod Calkins, Ph.D., Phone: 503-585-4978, Email: rcalkins@co.marion.or.us
Tamara Sale, Phone: 503.361.2796, Email: tsale@mvbcn.org
Rod Calkins, Ph.D., Principal Investigator

Describes the orientation of the program and early signs of psychosis

Describes the clinical and scientific basis for the program and information for professionals about psychosis and its prevention through early intervention.

Starting date: October 2007
Ending date: April 2011
Last updated: October 21, 2008