Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169988
Status:
COMPLETED
Last Update Posted:
2009-12-17
First Post:
2005-09-09
Brief Title:
Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Sertraline Alone vs in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None