Bipolar Disorder, Depression, Psychotic Disorders, Schizophrenia
Conditions
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
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.
Interventions
DRUGaripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
Oral, daily, generally at lower than manufacturer's recommendations
BEHAVIORALPsychoeducational 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
BEHAVIORALSupported employment and education
Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
Sponsors
Robert Wood Johnson Foundation
MaineHealth
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff. | 87 |
| Experimental Intervention 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. | 205 |
| Total | 292 |
Baseline characteristics
| Characteristic | Control Group | Experimental Intervention | Total |
|---|---|---|---|
| Age, Continuous | 16.23 years STANDARD_DEVIATION 3.18 | 16.40 years STANDARD_DEVIATION 3.3 | 16.35 years STANDARD_DEVIATION 3.26 |
| Psychotic symptoms | 4.15 units on a scale STANDARD_DEVIATION 1.76 | 11.99 units on a scale STANDARD_DEVIATION 3.42 | 9.65 units on a scale STANDARD_DEVIATION 4.69 |
| Region of Enrollment United States | 87 participants | 205 participants | 292 participants |
| Sex: Female, Male Female | 26 Participants | 89 Participants | 115 Participants |
| Sex: Female, Male Male | 61 Participants | 116 Participants | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 87 | 51 / 205 |
| serious Total, serious adverse events | 1 / 87 | 0 / 205 |
Outcome results
Primary
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.
Time frame: two years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Psychotic Symptoms | 9.2 units on a scale | Standard Deviation 1 |
| Family-aided Assertive Community Treatment | Psychotic Symptoms | 6.7 units on a scale | Standard Deviation 0.4 |
Comparison: The analysis used regression discontinuity methods, in which the baseline sum scores were adjusted and centered to an equalize control and experimental conditions.p-value: 0.0034Mixed Models Analysis