Prodromal Schizophrenia, Psychotic Disorders
Conditions
Keywords
clinical high risk, attenuated positive symptoms, attenuated negative symptoms, cognition, functional status, prodromal psychosis
Brief summary
The Recognition and Prevention (RAP) Program is conducting a research study comparing an antidepressant, sertraline, alone versus in combination with a second-generation antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts, suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention and social skills in adolescents.
Detailed description
Eligible patients are enrolled in a 16-week trial consisting of symptom and side effects ratings (10 visits), monthly blood and urine tests, and neuropsychological testing at the first and last visits. At the initial appointment, all patients are assigned to sertraline and are randomly assigned to an adjunctive risperidone or placebo group. The treating physician is also blind to the medication assignment, which allows both the doctor and the patient to assess side effects and symptom improvement, unbiased by expectation. All patients receive an active medication.
Interventions
DRUGrisperidone
DRUGsertraline-primary
Sponsors
Stanley Medical Research Institute
Janssen Pharmaceutica N.V., Belgium
Pfizer
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
* Participants are between the ages of 12 and 22. * Participants are English-speaking. * Participants are experiencing one or more symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences. * Participants meet additional RAP criteria (evaluated during screening and interview).
Exclusion criteria
* Participants have been diagnosed with an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features. * Participants have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain. * Participants have a medical condition that contraindicates treatment with sertraline or risperidone. * Participants have past or current substance dependence. * Participants are currently taking and responding well to antidepressant or antipsychotic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score on attenuated positive symptom scale at 16 weeks | — |
| Score on attenuated negative symptom scale at 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Score on social functioning measure at 16 weeks | — |
| Score on academic functioning measure at 16 weeks | — |
| Score on cognitive measures at 16 weeks | — |
Countries
United States
Outcome results
None listed