Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462196
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-14
Brief Title:
Natural History of Depression Bipolar Disorder and Suicide Risk
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History of Depression Bipolar Disorder and Suicide Risk
Status:
RECRUITING
Status Verified Date:
2024-08-30
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:
Mood disorders such as depression and bipolar disorder are difficult to treat One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments In this study researchers want to perform tests on people undergoing clinical care for mood disorders The purpose is to understand the experience of receiving treatment for depression bipolar disorder and suicide risk We also hope that this study will help us to predict which medications will improve thoughts of suicide
People 18 years or older who are receiving treatment for depression bipolar disorder or suicide risk may take part in this study Participants must have also been enrolled in protocol 01-M-0254
This study will be conducted at the NIH Clinical Center in Bethesda MD The study typically lasts up to 12 weeks but may last longer if a participant s treatment continues past that time
Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder Other tests are optional and include psychological testing blood draws sleep tests and imaging scans These will be done at the start and the end of research participation
People 18 years or older who are receiving treatment for depression bipolar disorder or suicide risk may take part in this study Participants must have also been enrolled in protocol 01-M-0254
This study will be conducted at the NIH Clinical Center in Bethesda MD The study typically lasts up to 12 weeks but may last longer if a participant s treatment continues past that time
Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder Other tests are optional and include psychological testing blood draws sleep tests and imaging scans These will be done at the start and the end of research participation
Detailed Description:
Study Description
This proposal would collect systematic data on individuals undergoing personalized treatments for depression bipolar disorder and suicide risk within the Experimental Therapeutics and Pathophysiology Branch ETPB The ETPB recruits individuals with treatment-resistant mood disorders from around the country After research participation they are often offered a course of standard treatment tailored to clinical needs for clinical stabilization and discharge back to non-NIH clinicians This protocol would allow for clinical ratings in-person and remotely throughout clinical standard treatments as well as neurobiological procedures at baseline and study termination to identify potential clinical and demographic predictors and biomarkers of treatment response
Objectives
The primary objective is to identify predictors of antidepressant treatment response
The secondary and tertiary objectives are to identify predictors of suicide ideation response to treatment and biomarkers of antidepressant response to treatment respectively
Endpoints
Primary Endpoint Score on the Montgomery Asberg Depression Rating Scale
Secondary Endpoint Score on the Scale for Suicidal Ideation
This proposal would collect systematic data on individuals undergoing personalized treatments for depression bipolar disorder and suicide risk within the Experimental Therapeutics and Pathophysiology Branch ETPB The ETPB recruits individuals with treatment-resistant mood disorders from around the country After research participation they are often offered a course of standard treatment tailored to clinical needs for clinical stabilization and discharge back to non-NIH clinicians This protocol would allow for clinical ratings in-person and remotely throughout clinical standard treatments as well as neurobiological procedures at baseline and study termination to identify potential clinical and demographic predictors and biomarkers of treatment response
Objectives
The primary objective is to identify predictors of antidepressant treatment response
The secondary and tertiary objectives are to identify predictors of suicide ideation response to treatment and biomarkers of antidepressant response to treatment respectively
Endpoints
Primary Endpoint Score on the Montgomery Asberg Depression Rating Scale
Secondary Endpoint Score on the Scale for Suicidal Ideation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 001874-M | None | None | None |