Early Detection and Intervention for the Prevention of Psychosis (EDIPP)
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|ClinicalTrials.gov Identifier: NCT00531518|
Recruitment Status : Completed
First Posted : September 19, 2007
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
|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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||292 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Early Detection and Intervention for the Prevention of Psychosis Project|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||September 2013|
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
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
Behavioral: Supported employment and education
Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
- Psychotic Symptoms [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531518
|United States, California|
|University of California-Davis, Imaging Research Center|
|Sacramento, California, United States, 95817|
|United States, Maine|
|Portland Identification and Early Referral Program|
|Portland, Maine, United States, 04102|
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48108|
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131-0001|
|United States, New York|
|Zucker Hillside Hosptial|
|Glen Oaks, New York, United States, 11004|
|United States, Oregon|
|Mid-Valley Behavioral Care Network|
|Salem, Oregon, United States, 97301|
|Principal Investigator:||William R. McFarlane, M.D.||Maine Medical Center|