Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186043
Status:
COMPLETED
Last Update Posted:
2017-09-27
First Post:
2005-09-12
Brief Title:
Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial of Seroquel for the Treatment of Dysphoric Hypomania in Bipolar II Patients
Status:
COMPLETED
Status Verified Date:
2017-09
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:
1 The primary objective of this study is to examine the efficacy of quetiapine Seroquel in treatment of dysphoric hypomania in patients with Bipolar II disorder
2 To evaluate the utility of Seroquel add-on treatment to decrease mixed depressive and hypomanic symptoms
2 To evaluate the utility of Seroquel add-on treatment to decrease mixed depressive and hypomanic symptoms
Detailed Description:
Bipolar disorder is recognized as a severe and treatment-refractory illness Recent work from multiple research centers in both Europe and the US have found the percentage of patients experiencing hypomania that are also experiencing depressive symptoms is substantial In a recent Stanley Foundation Bipolar Network study it was found that 60 of all visits with at least moderate hypomania were associated with depressive symptoms It is generally agreed that patients experiencing mixed states or combinations of mania with depressive symptoms are less responsive to older treatments such as lithium Swann et al 1997 We propose evaluating the response to Seroquel add-on versus placebo add-on for those patients experiencing hypomania and depressive symptoms either simultaneously or closely juxtaposed within a 2-3 day period
Bipolar II BDII patients make up a substantial percentage of patients with bipolar disorder estimated conservatively at 05 of the US population and with somewhat more liberal definitions of hypomania minimum duration in Europe at 1 or greater Importantly few to virtually no recent treatment trials of high quality have been undertaken in BDII Treatment guidelines and algorithms for bipolar disorder have been unable to specify defined treatments for BDII due to the lack of studies Juxtaposed to the limits of controlled data preliminary case series and clinical experience support atypical antipsychotics will be helpful for BDII patients Thus the impact is high for a placebo controlled study of Seroquel in BDII
We believe that this study is important to undertake because of the limited controlled data available for the treatment and management of patients with bipolar II disorder in outpatient settings Numerous placebo-controlled monotherapy studies have been completed in inpatient settings for bipolar I many leading to FDA submissions for registration Maintenance trials are underway or are being developed for bipolar I disorder There are no medications specifically approved for use in bipolar II patients at this time
Additionally the initial trials for the registration of Seroquel for bipolar disorder did not include patients with mixed symptoms Clear cut-offs were provided in order to minimize the likelihood that patients with mixed symptoms would enter these trials Thus the trial proposed will provide data useful to the clinician in a real world setting as well as provide data in an area not previously covered by the trial registration studies We hypothesize that Seroquel will be effective to treat such symptoms in patients with BDII
A clinically important and ground breaking aspect of the proposed trial is the focus on patients with bipolar II disorder There is a paucity of data available to evaluate the use of atypical antipsychotics in patients with bipolar II disorder Preliminary data of any sort in this area will be clinically useful set the stage for larger more definitive trials and translate readily into practice
Bipolar II BDII patients make up a substantial percentage of patients with bipolar disorder estimated conservatively at 05 of the US population and with somewhat more liberal definitions of hypomania minimum duration in Europe at 1 or greater Importantly few to virtually no recent treatment trials of high quality have been undertaken in BDII Treatment guidelines and algorithms for bipolar disorder have been unable to specify defined treatments for BDII due to the lack of studies Juxtaposed to the limits of controlled data preliminary case series and clinical experience support atypical antipsychotics will be helpful for BDII patients Thus the impact is high for a placebo controlled study of Seroquel in BDII
We believe that this study is important to undertake because of the limited controlled data available for the treatment and management of patients with bipolar II disorder in outpatient settings Numerous placebo-controlled monotherapy studies have been completed in inpatient settings for bipolar I many leading to FDA submissions for registration Maintenance trials are underway or are being developed for bipolar I disorder There are no medications specifically approved for use in bipolar II patients at this time
Additionally the initial trials for the registration of Seroquel for bipolar disorder did not include patients with mixed symptoms Clear cut-offs were provided in order to minimize the likelihood that patients with mixed symptoms would enter these trials Thus the trial proposed will provide data useful to the clinician in a real world setting as well as provide data in an area not previously covered by the trial registration studies We hypothesize that Seroquel will be effective to treat such symptoms in patients with BDII
A clinically important and ground breaking aspect of the proposed trial is the focus on patients with bipolar II disorder There is a paucity of data available to evaluate the use of atypical antipsychotics in patients with bipolar II disorder Preliminary data of any sort in this area will be clinically useful set the stage for larger more definitive trials and translate readily into practice
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