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Early Detection and Intervention for the Prevention of Psychosis (EDIPP)

Primary Purpose

Schizophrenia, Bipolar Disorder, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
Psychoeducational multifamily group treatment
Supported employment and education
Sponsored by
MaineHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring 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

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California-Davis, Imaging Research Center
  • Portland Identification and Early Referral Program
  • Washtenaw County
  • University of New Mexico
  • Zucker Hillside Hosptial
  • Mid-Valley Behavioral Care Network

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Family-aided Assertive Community Treatment

Arm Description

This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.

This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .

Outcomes

Primary Outcome Measures

Psychotic Symptoms
Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2007
Last Updated
July 6, 2016
Sponsor
MaineHealth
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00531518
Brief Title
Early Detection and Intervention for the Prevention of Psychosis
Acronym
EDIPP
Official Title
Early Detection and Intervention for the Prevention of Psychosis Project
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MaineHealth
Collaborators
Robert Wood Johnson Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
Arm Title
Family-aided Assertive Community Treatment
Arm Type
Experimental
Arm Description
This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .
Intervention Type
Drug
Intervention Name(s)
aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
Other Intervention Name(s)
Abilify, Prozac, Welbutrin, Zoloft, Lamictal
Intervention Description
Oral, daily, generally at lower than manufacturer's recommendations
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational multifamily group treatment
Other Intervention Name(s)
Family psychoeducation,, Family behavioral therapy, Multiple family group therapy
Intervention Description
Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work
Intervention Type
Behavioral
Intervention Name(s)
Supported employment and education
Other Intervention Name(s)
Supported employment, Supported education
Intervention Description
Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
Primary Outcome Measure Information:
Title
Psychotic Symptoms
Description
Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William R. McFarlane, M.D.
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California-Davis, Imaging Research Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Portland Identification and Early Referral Program
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Washtenaw County
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
Zucker Hillside Hosptial
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
Mid-Valley Behavioral Care Network
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Currently, on request, data will be shared with legitimate organizations for specific analyses approved by the PI and the Maine Medical Center Institutional Review Board.
Citations:
PubMed Identifier
26766751
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.
Results Reference
result
PubMed Identifier
25065017
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. Erratum In: Schizophr Bull. 2015 Mar;41(2):532.
Results Reference
result
Links:
URL
http://www.preventmentalillness.org
Description
Describes the orientation of the program and early signs of psychosis

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Early Detection and Intervention for the Prevention of Psychosis

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