NCT00531518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 years until next milestone

Results Posted

Study results publicly available

August 15, 2016

Completed
Last Updated

August 15, 2016

Status Verified

July 1, 2016

Enrollment Period

5.6 years

First QC Date

September 18, 2007

Results QC Date

January 20, 2016

Last Update Submit

July 6, 2016

Conditions

SchizophreniaBipolar DisorderDepressionPsychotic Disorders

Keywords

SchizophreniaBipolar disorderPsychosisProdromal psychosisFamily psychoeducationSupported educationSupported employmentUlra-high-risk for psychosisMajor depressionBipolar disorder, with psychotic featuresMajor depression, with psychotic featuresAttenuated, prodromal psychotic symptoms

Outcome Measures

Primary Outcomes (1)

  • 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.

    two years

Study Arms (2)

Control group

NO INTERVENTION

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

Family-aided Assertive Community Treatment

EXPERIMENTAL

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 .

Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigineBehavioral: Psychoeducational multifamily group treatmentBehavioral: Supported employment and education

Interventions

aripiprazole; fluoxetine; bupropion; sertraline; lamotrigineDRUG

Oral, daily, generally at lower than manufacturer's recommendations

Also known as: Abilify, Prozac, Welbutrin, Zoloft, Lamictal
Family-aided Assertive Community Treatment
Psychoeducational multifamily group treatmentBEHAVIORAL

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

Also known as: Family psychoeducation,, Family behavioral therapy, Multiple family group therapy
Family-aided Assertive Community Treatment
Supported employment and educationBEHAVIORAL

Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.

Also known as: Supported employment, Supported education
Family-aided Assertive Community Treatment

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California-Davis, Imaging Research Center

Sacramento, California, 95817, United States

Location

Portland Identification and Early Referral Program

Portland, Maine, 04102, United States

Location

Washtenaw County

Ann Arbor, Michigan, 48108, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

Location

Zucker Hillside Hosptial

Glen Oaks, New York, 11004, United States

Location

Mid-Valley Behavioral Care Network

Salem, Oregon, 97301, United States

Location

Related Publications (2)

  • 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.

    PMID: 26766751RESULT

  • 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.

    PMID: 25065017RESULT

Related Links

MeSH Terms

Conditions

SchizophreniaBipolar DisorderDepressionPsychotic DisordersDepressive Disorder, Major

Interventions

AripiprazoleFluoxetineBupropionSertralineLamotriginePsychotherapy, GroupEmployment, SupportedEducational Status

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersBehavioral SymptomsBehaviorDepressive Disorder

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPropylaminesAminesOrganic ChemicalsPropiophenonesKetones1-NaphthylamineNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsTriazinesSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesEmploymentSocioeconomic FactorsPopulation CharacteristicsRehabilitation, VocationalRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
William R McFarlane, M.D.
Organization
Maine Medical Center Research Institute
mcfarw@mmc.org
207-662-4348

Study Officials

  • William R. McFarlane, M.D.

    MaineHealth

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 19, 2007

Study Start

October 1, 2007

Primary Completion

May 1, 2013

Study Completion

September 1, 2013

Last Updated

August 15, 2016

Results First Posted

August 15, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

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.

Locations

US(6)