Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044616
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2002-09-03
Brief Title:
Relapse Prevention for Bipolar Type-II Disorder
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Relapse Prevention of Bipolar Type-II Disorder
Status:
COMPLETED
Status Verified Date:
2013-12
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:
This 62-week study will compare the safety and effectiveness of fluoxetine Prozac lithium the combination of these two medications and placebo in treating and preventing recurrent depressive episodes in people with bipolar type II disorder
Detailed Description:
Bipolar II BP II disorder is characterized by a high recurrence of major depressive episodes MDE and it is associated with substantial illness and deaths Unfortunately relatively little attention has been given to treatment of BP II Concern that patients may switch from depressed to manic states during treatment of MDE has impeded the development of effective treatments for BP II MDE
BP II MDE patients are treated initially with fluoxetine for 10 weeks Patients who recover from MDE are then randomized to receive a relapse-prevention treatment of fluoxetine lithium a combination of fluoxetine and lithium or placebo for 1 year Patients undergo clinical and laboratory evaluations including physical examinations bloodwork thyroid function tests electrocardiogram ECG urinalysis and HAM-D YMR CGI-S CGI-I and adverse events scales
For information on a related study please follow this link
httpclinicaltrialsgovshowNCT00602537
BP II MDE patients are treated initially with fluoxetine for 10 weeks Patients who recover from MDE are then randomized to receive a relapse-prevention treatment of fluoxetine lithium a combination of fluoxetine and lithium or placebo for 1 year Patients undergo clinical and laboratory evaluations including physical examinations bloodwork thyroid function tests electrocardiogram ECG urinalysis and HAM-D YMR CGI-S CGI-I and adverse events scales
For information on a related study please follow this link
httpclinicaltrialsgovshowNCT00602537
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 83-ATP | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH060353-01 |
| R01MH060353-01 | NIH | None | None |