Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001652
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
The Evaluation and Follow-up of Patients With Bipolar Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Evaluation and Naturalistic Follow-up of Patients With Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2002-12
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:
The purpose of this research protocol is to screen and enroll individuals who have bipolar disorder and to track each persons course of illness in order to study the long-term course of illness and to elucidate possible clinical and biological predictors of acute and sustained treatment response As a part of this protocol subjects will systematically be administered psychiatric rating scales such as the life-chart method LCM for daily assessment of mood sleep and behavior be asked to participate in non-invasive research procedures such as blood drawing for measurement of thyroid antibodies and intracellular calcium and be medicated as is clinically appropriate This protocol also serves as a stepping stone to other protocols such as the comparative acute and long-term efficacy of three antidepressants 95-M-0129 and the efficacy of omega-3 fatty acids 00-M-0004 for which separate written informed consents are obtained Patients in this study are participants in the larger NIMH-Stanley Foundation Bipolar Network SFBN which involves six academic sites focused on better understanding the long-term course and treatment of the illness The current protocol thus serves as an entry point for individuals with bipolar disorder for screening and detailed longitudinal assessment both prior to and in between more formal blind randomized IRB approved treatment protocols
Detailed Description:
The purpose of this research protocol is to screen and enroll individuals who have bipolar disorder and to track each persons course of illness in order to study the long-term course of illness and to elucidate possible clinical and biological predictors of acute and sustained treatment response As a part of this protocol subjects will systematically be administered psychiatric rating scales such as the life-chart method LCM for daily assessment of mood sleep and behavior be asked to participate in non-invasive research procedures such as blood drawing for measurement of thyroid antibodies and intracellular calcium and be medicated as is clinically appropriate This protocol also serves as a stepping stone to other protocols such as the comparative acute and long-term efficacy of three antidepressants 95-M-0129 and the efficacy of omega-3 fatty acids 00-M-0004 for which separate written informed consents are obtained Patients in this study are participants in the larger NIMH-Stanley Foundation Bipolar Network SFBN which involves six academic sites focused on better understanding the long-term course and treatment of the illness The current protocol thus serves as an entry point for individuals with bipolar disorder for screening and detailed longitudinal assessment both prior to and in between more formal blind randomized IRB approved treatment protocols
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 |
|---|---|---|---|
| 97-M-0039 | None | None | None |