aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine
DrugOral, daily, generally at lower than manufacturer's recommendations
Other names: Abilify, Prozac, Welbutrin, Zoloft, Lamictal
NCT Number: NCT00531518
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.
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Notify Me12 year–25 year
All sexes
Interventional
Not applicable
University of California-Davis, Imaging Research Center, Sacramento, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral, daily, generally at lower than manufacturer's recommendations
Other names: Abilify, Prozac, Welbutrin, Zoloft, Lamictal
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
Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.
Other names: Supported employment, Supported education
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.
MaineHealth
Other
Early Detection and Intervention for the Prevention of Psychosis Project
Acronym: EDIPP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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