Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00314327
Status:
TERMINATED
Last Update Posted:
2018-05-16
First Post:
2006-04-11
Brief Title:
Optimizing Response in Psychosis Study
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Optimizing Response in Psychosis Study
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment for the study was limited
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORP
Brief Summary:
The purpose of this project is to evaluate the efficacy of long-acting risperidone for patients with first episode schizophrenia spectrum who did not improve sufficiently with the first antipsychotic medication they tried during their initial treatment trial
Detailed Description:
The goal of the proposed pilot study is to investigate the feasibility and efficacy of the long-acting injectable form of the second generation antipsychotic risperidone for the treatment of first episode patients who fail to respond to 12 weeks of treatment with an oral antipsychotic The rationale for using this long-acting medication is that it eliminates covert non-adherence which may be a factor in poor response In addition pharmacokinetic and pharmacodynamic differences between injectable and oral formulations may result in differences in treatment response favoring the injectable form Subjects who have not responded sufficiently to treatment with an antipsychotic will be approached for the proposed long-acting risperidone trial Risperidone treatment will be open label with titration based upon individual response within FDA approved dose ranges Treatment will begin with a phase of supplementation with oral risperidone Subjects will stop their previous antipsychotic start 2 mg of oral risperidone per day for one day and then increase the dose to 4 mg per day Subjects who tolerate one week of oral risperidone will then begin injections of 25 mg long-acting risperidone every 2 weeks for a total of 12 weeks If clinically indicated the dose may be increased up to a maximum of 50 mg as per FDA guidelines
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