N/A
N=292
Early Detection and Intervention for the Prevention of Psychosis
Schizophrenia · Bipolar Disorder · Depression · Psychotic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00531518 ↗Enrolled (actual)
292
Serious AEs
0.3%
Results posted
Aug 2016
Primary outcome: Primary: Psychotic Symptoms — 9.2; 6.7 units on a scale — p=.0034
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine (Drug); Psychoeducational multifamily group treatment (Behavioral); Supported employment and education (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- MaineHealth
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psychotic Symptoms |
9.2; 6.7 | .0034 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00531518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.