Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

Northwell Health

Status

Completed

Conditions

Psychotic Disorders

Prodromal Schizophrenia

Treatments

Drug: sertraline-primary

Drug: risperidone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00169988

05-04-103

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

12 to 22 years old

Volunteers

No Healthy Volunteers

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