Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409201
Status:
UNKNOWN
Last Update Posted:
2006-12-08
First Post:
2006-12-07
Brief Title:
Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia
Sponsor:
Abarbanel Mental Health Center
Organization:
Abarbanel Mental Health Center
Study Overview
Official Title:
Phase 1 Study of Reboxetine Adjuvant Therapy and Cognitive and Behavioral Measures
Status:
UNKNOWN
Status Verified Date:
2006-03
Last Known Status:
RECRUITING
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:
30 patients will randomly be selected and will be administered either reboxetine or a placebo changes in cognition and behavior will be assessed by computer tests and scales during a six week study period
Detailed Description:
all participants will be administered panss sans esrs calgary progesterom sexual functioning scale ham-a covy hamilton depression scale and cgi and cgi improved rating on the first visit as well as blood tests ecg and weight they will then be tested using a computer cognitive test cogscan test that lasts about 45 minutes next they will be given either a two week dose of placebo or treatment 2 mg 2 daily for first week then 4 mg day 2 mg night for the second week after two weeks they the dose is increased to 4 mg 2 daily at four weeks all tests are readministered as well as at six weeks the study is concluded at 6 weeks following a readministration of tests physical examination is also administered at the conclusion
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