Clinical trial NCT00169988: Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms
Official title: Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prodromal Schizophrenia
Psychotic Disorders
Keywords: clinical high risk
attenuated positive symptoms
attenuated negative symptoms
cognition
functional status
prodromal psychosis
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
name: Janssen Pharmaceutica N.V., Belgium
name: Pfizer
First posted: 2005-09-15
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score on attenuated positive symptom scale at 16 weeks
measure: Score on attenuated negative symptom scale at 16 weeks
Secondary outcomes:
measure: Score on social functioning measure at 16 weeks
measure: Score on academic functioning measure at 16 weeks
measure: Score on cognitive measures at 16 weeks
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
state: New York
Study officials:
affiliation: Long Island Jewish Medical Center (LIJMC)
name: Barbara A Cornblatt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: LIJMC
name: Christoph U Correll, MD
role: STUDY_DIRECTOR
References: