Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374543
Status:
TERMINATED
Last Update Posted:
2014-04-16
First Post:
2006-09-08
Brief Title:
Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Ziprasidone for the Treatment of Generalized Anxiety Comorbidity in Patients With Bipolar Disorder
Status:
TERMINATED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment goal could not be achieved
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes bipolar symptoms and on measures of quality of life and resilience
Detailed Description:
This study would be the first prospective placebo-controlled study to our knowledge of any pharmacotherapy strategy for the treatment of comorbid generalized anxiety or any comorbid anxiety in patients with bipolar disorder Our hypotheses are
1 Ziprasidone flexibly dosed from 40 to 160 mgday will reduce anxiety symptoms significantly more than placebo in patients with bipolar disorder who have a full or subsyndromal diagnosis of generalized anxiety disorder GAD
2 Ziprasidone will be well tolerated in patients with generalized anxiety based on the incidence of treatment emergent adverse effects during 8 weeks of therapy and based on a lack of worsening of bipolar depression mania or hypomania compared to placebo
3 Treatment with ziprasidone will have a significantly greater positive impact on measures of quality of life and resilience than placebo
1 Ziprasidone flexibly dosed from 40 to 160 mgday will reduce anxiety symptoms significantly more than placebo in patients with bipolar disorder who have a full or subsyndromal diagnosis of generalized anxiety disorder GAD
2 Ziprasidone will be well tolerated in patients with generalized anxiety based on the incidence of treatment emergent adverse effects during 8 weeks of therapy and based on a lack of worsening of bipolar depression mania or hypomania compared to placebo
3 Treatment with ziprasidone will have a significantly greater positive impact on measures of quality of life and resilience than placebo
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