Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877977
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2021-05-06
Brief Title:
Long-term Observation of Participants With Mood Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Long-term Observation of Participants With Mood Disorders
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:
Background
More than 12000 people have taken part in research at the Experimental Therapeutics Pathophysiology Branch at the National Institute of Mental Health Intramural Program This has led to advances in the treatment of depression bipolar disorder and suicide risk Researchers want to follow up with this group to see if they continue to have mental health symptoms and receive psychiatric treatments
Objective
To learn the long-term impact of depression bipolar disorder and suicide risk
Eligibility
Adults ages 18 and older who signed consent for Protocol 01-M-0254 over a year ago
Design
This study has 2 phases an online phase and a telephone phase It has no in-person or face-to-face contact
In Phase 1 participants will fill out online surveys They will access the surveys through the study website The questions will focus on their current thoughts and feelings The surveys will also ask about their current treatments for their mental health symptoms At the end of the surveys they will be asked if they would like to take part in Phase 2 If so they will mark yes Phase 2 includes a phone interview They will be contacted by email to schedule the interview
In Phase 2 participants will be asked more in-depth questions about how they are feeling They will also be asked which psychiatric medicines and treatments they have used since they left NIH
In both phases participants can skip any questions they do not want to answer
The online surveys will take 30 minutes to complete The phone interview will last 1-4 hours
The information that participants give in this study may be linked to their other NIH research records
More than 12000 people have taken part in research at the Experimental Therapeutics Pathophysiology Branch at the National Institute of Mental Health Intramural Program This has led to advances in the treatment of depression bipolar disorder and suicide risk Researchers want to follow up with this group to see if they continue to have mental health symptoms and receive psychiatric treatments
Objective
To learn the long-term impact of depression bipolar disorder and suicide risk
Eligibility
Adults ages 18 and older who signed consent for Protocol 01-M-0254 over a year ago
Design
This study has 2 phases an online phase and a telephone phase It has no in-person or face-to-face contact
In Phase 1 participants will fill out online surveys They will access the surveys through the study website The questions will focus on their current thoughts and feelings The surveys will also ask about their current treatments for their mental health symptoms At the end of the surveys they will be asked if they would like to take part in Phase 2 If so they will mark yes Phase 2 includes a phone interview They will be contacted by email to schedule the interview
In Phase 2 participants will be asked more in-depth questions about how they are feeling They will also be asked which psychiatric medicines and treatments they have used since they left NIH
In both phases participants can skip any questions they do not want to answer
The online surveys will take 30 minutes to complete The phone interview will last 1-4 hours
The information that participants give in this study may be linked to their other NIH research records
Detailed Description:
Study Description The proposal will leverage existing data on former participants with mood disorders collected in the Experimental Therapeutics and Pathophysiology Branch in order to identify predictors of long-term depressive symptoms suicide attempts and ketamine utilization The ETPB has collected a wealth of clinical biologic neuroimaging and sleep data on individuals with treatment resistant depression and bipolar disorder over the last 20 years This study would re-contact these individuals for online and telephone assessment of current symptoms We would then determine the ability of these clinical and biological measures to predict long-term outcomes For individuals who do not participate in online or telephone data collection we would like to identify incidence of premature death including suicide using linkage to data sources such as the National Death Index We will also use this protocol for recruitment for in-person neurobiological studies and clinical trials of treatment resistant depression bipolar disorder and suicide risk both for ETPB and other branches of the NIMH IRP
Objectives The primary objective is to identify predictors of long-term treatment-resistant depression The secondary and tertiary objectives are to identify predictors of long-term risk for suicide attempt and identify predictors of repeat use of ketamine respectively
Endpoints
Primary Endpoint Score on Beck Depression Inventory
Secondary Endpoint Self-reported suicide attempt after NIH study participation
Secondary Endpoint Self-reported ketamine utilization after NIH study participation
Secondary Endpoint Suicide death as reported by the National Death Index
Study Population The sample size will be up to 1000 participants who previously signed consent into Protocol 01-M-0254 The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers and will include participants 18 years and older any gender and health status
Description of SitesFacilities Enrolling Participants The study will be conducted online through a secure study website Data collection can also occur over the phone
Study Duration 1 year
Participant Duration 20 minutes- 4 hours
Objectives The primary objective is to identify predictors of long-term treatment-resistant depression The secondary and tertiary objectives are to identify predictors of long-term risk for suicide attempt and identify predictors of repeat use of ketamine respectively
Endpoints
Primary Endpoint Score on Beck Depression Inventory
Secondary Endpoint Self-reported suicide attempt after NIH study participation
Secondary Endpoint Self-reported ketamine utilization after NIH study participation
Secondary Endpoint Suicide death as reported by the National Death Index
Study Population The sample size will be up to 1000 participants who previously signed consent into Protocol 01-M-0254 The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers and will include participants 18 years and older any gender and health status
Description of SitesFacilities Enrolling Participants The study will be conducted online through a secure study website Data collection can also occur over the phone
Study Duration 1 year
Participant Duration 20 minutes- 4 hours
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 |
|---|---|---|---|
| 000375-M | None | None | None |