Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167479
Status:
COMPLETED
Last Update Posted:
2006-09-11
First Post:
2005-09-10
Brief Title:
A Study of Risperidone Monotherapy in Bipolar Anxiety
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Current at Least Moderately Severe Anxiety and Lifetime Panic Disorder or Generalized Anxiety Disorder
Status:
COMPLETED
Status Verified Date:
2006-09
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 specific aim of this study is to evaluate the efficacy tolerability and safety of risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety
Detailed Description:
This is a randomized double-blind placebo controlled parallel-group 8-week trial of risperidone monotherapy in outpatient subjects with a lifetime bipolar I II or NOS disorder a lifetime panic or generalized anxiety disorder and current at least moderately severe anxiety symptoms Approximately 90 subjects will be enrolled to obtain 60 subjects who complete the 8-week trial Subjects will be randomized to risperidone or placebo in a 11 ratio No concomitant psychotropic medication will be allowed except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms and prn zolpidem and zaleplon throughout the study for the management of insomnia Throughout the study psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RIS-BIP-408 | None | None | None |