Clinical Trial: Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms
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 Summary: 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.
Sponsor: Northwell Health
Current Primary Outcome:
- Score on attenuated positive symptom scale at 16 weeks
- Score on attenuated negative symptom scale at 16 weeks
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Score on social functioning measure at 16 weeks
- Score on academic functioning measure at 16 weeks
- Score on cognitive measures at 16 weeks
Original Secondary Outcome: Same as current
Information By: Northwell Health
Dates:
Date Received: September 9, 2005
Date Started: March 2004
Date Completion:
Last Updated: December 16, 2009
Last Verified: October 2007
