EDIPP: Early Detection and Intervention for the Prevention of Psychosis

• Sponsor: MaineHealth (Other)
• Overall Status: Completed
• CT.gov ID: NCT00531518
• Collaborator: Robert Wood Johnson Foundation (Other)
• Enrollment: 292
• Locations: 6
• Arms: 2
• Duration (Months): 71
• Patients Per Site: 48.7
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Bipolar Disorder; Depression; Psychotic Disorders	Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine; Behavioral: Psychoeducational multifamily group treatment; Behavioral: Supported employment and education	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 292 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Early Detection and Intervention for the Prevention of Psychosis Project
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
Experimental: Family-aided Assertive Community Treatment 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; lamotrigine; Oral, daily, generally at lower than manufacturer's recommendations; Other Names: Abilify Prozac Welbutrin Zoloft Lamictal ; Behavioral: Psychoeducational multifamily group treatment; 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; Other Names: Family psychoeducation, Family behavioral therapy Multiple family group therapy ; Behavioral: Supported employment and education; Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.; Other Names: Supported employment Supported education

Outcome Measures

Primary Outcome Measures

1. Psychotic Symptoms [two years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California-Davis, Imaging Research Center	Sacramento	California	United States	95817
2	Portland Identification and Early Referral Program	Portland	Maine	United States	04102
3	Washtenaw County	Ann Arbor	Michigan	United States	48108
4	University of New Mexico	Albuquerque	New Mexico	United States	87131-0001
5	Zucker Hillside Hosptial	Glen Oaks	New York	United States	11004
6	Mid-Valley Behavioral Care Network	Salem	Oregon	United States	97301

Sponsors and Collaborators

• MaineHealth
• Robert Wood Johnson Foundation

Investigators

• Principal Investigator: William R. McFarlane, M.D., MaineHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William McFarlane, Principal Investigator, MaineHealth
• ClinicalTrials.gov Identifier: NCT00531518
• Other Study ID Numbers: 58920; RWJF #58920
• First Posted: Sep 19, 2007
• Last Update Posted: Aug 15, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by William McFarlane, Principal Investigator, MaineHealth: 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
• Additional relevant MeSH terms: Disease; Depression; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders; Lamotrigine; Aripiprazole; Bupropion; Fluoxetine; Sertraline

Study Results

Participant Flow

Arm/Group Title	Control Group	Family-aided Assertive Community Treatment
Arm/Group 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 . aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations Psychoeducational multifamily group treatment: 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 Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
Period Title: Overall Study
STARTED	87	205
COMPLETED	55	134
NOT COMPLETED	32	71

Baseline Characteristics

Arm/Group Title	Control Group	Experimental Intervention	Total
Arm/Group 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 . aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations Psychoeducational multifamily group treatment: 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 Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.	Total of all reporting groups
Overall Participants	87	205	292
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.23 (3.18)	16.40 (3.30)	16.35 (3.26)
Sex: Female, Male (Count of Participants)
Female	26 29.9%	89 43.4%	115 39.4%
Male	61 70.1%	116 56.6%	177 60.6%
Region of Enrollment (participants) [Number]
United States	87 100%	205 100%	292 100%
Psychotic symptoms (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.15 (1.76)	11.99 (3.42)	9.65 (4.69)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Family-aided Assertive Community Treatment
Arm/Group 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 . aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations Psychoeducational multifamily group treatment: 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 Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
Measure Participants	87	205
Mean (Standard Deviation) [units on a scale]	9.2 (1.0)	6.7 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Family-aided Assertive Community Treatment
	Comments	The analysis used regression discontinuity methods, in which the baseline sum scores were adjusted and centered to an equalize control and experimental conditions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.0034
	Comments	The final analysis included adjstment for site and baseline sum psychotic symptom score.
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Over 24 months
Arm/Group Title	Control Group		Family-aided Assertive Community Treatment
Arm/Group 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 . aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations Psychoeducational multifamily group treatment: 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 Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
All Cause Mortality
	Control Group		Family-aided Assertive Community Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Family-aided Assertive Community Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/87 (1.1%)		0/205 (0%)
Psychiatric disorders
suicide	1/87 (1.1%)	1	0/205 (0%)	0
Other (Not Including Serious) Adverse Events
	Control Group		Family-aided Assertive Community Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/87 (21.8%)		51/205 (24.9%)
Psychiatric disorders
Negative events	19/87 (21.8%)	19	51/205 (24.9%)	51

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.