Long-term Observation of Participants With Mood Disorders
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| ClinicalTrials.gov Identifier: NCT04877977 |
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Recruitment Status :
Recruiting
First Posted : May 7, 2021
Last Update Posted : April 19, 2023
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Background:
More than 12,000 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.
| Condition or disease |
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| Depression Suicide Risk |
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. 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
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 including both individuals with mood or anxiety disorders and healthy volunteers.
Description of Sites/Facilities Enrolling Participants: The study will be conducted online through a secure study website. Data collection can also occur over the phone.
Study Duration: 1.5 years
Participant Duration: 20 minutes- 4 hours
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Long-term Observation of Participants With Mood Disorders |
| Actual Study Start Date : | August 17, 2021 |
| Estimated Primary Completion Date : | October 1, 2023 |
| Estimated Study Completion Date : | October 1, 2023 |
| Group/Cohort |
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Healthy Volunteers
Individuals who previously signed consent for ETPB research as healthy volunteers
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Mood Disorder Patients
Individuals with mood disorders who previously signed consent for ETPB research
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- Score on Beck Depression Inventory (suicide item removed) [ Time Frame: Follow-up assessment ]Rating of depression without assessment of suicidal ideation
- Self-reported suicide attempt [ Time Frame: Follow-up assessment ]Self-reported suicide attempt since leaving NIH
- Ketamine utilization at non-NIH facility [ Time Frame: Follow-up assessment ]Participants will report whether they accessed ketamine/esketamine after leaving NIH
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Participants who signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers over a year ago.
- Age 18 years or older
- Able to provide informed consent online using study website or over the telephone
- Able to read and write English
EXCLUSION CRITERIA:
None.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877977
| Contact: Elizabeth D Ballard, Ph.D. | (301) 435-9399 | elizabeth.ballard@nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Elizabeth Ballard, Ph.D. 301-435-9399 elizabeth.ballard@nih.gov | |
| Principal Investigator: | Elizabeth D Ballard, Ph.D. | National Institute of Mental Health (NIMH) |
| Responsible Party: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT04877977 |
| Other Study ID Numbers: |
10000375 000375-M |
| First Posted: | May 7, 2021 Key Record Dates |
| Last Update Posted: | April 19, 2023 |
| Last Verified: | April 17, 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | .Clinical and demographic and biomarker participant data collected during the trial, after deidentification. |
| Supporting Materials: |
Statistical Analysis Plan (SAP) |
| Time Frame: | Starting within 1 year of completion of the study |
| Access Criteria: | Branch Chief will review requests and access will need to be approved by the NIMH/DIRP SD and OCD NIMH and the NIH IIRB. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Depression Suicide Ketamine |
Neuroimaging Treatment Resistant Depression Natural History |
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Depression Suicide Mood Disorders |
Behavioral Symptoms Mental Disorders Self-Injurious Behavior |