DepressionNCT04877977
Long-term Observation of Participants With Mood Disorders
An observational study of Depression and Suicide Risk, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Suicide Risk
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2021to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study involves re-contacting former participants of 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers for participation in this follow-up study.
Who may be able to join
- 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
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Elizabeth Ballard, Ph.D., 301-435-9399, elizabeth.ballard@nih.gov
About this study
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.
Read more
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.
Read the 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 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 year
Participant Duration: 20 minutes- 4 hours
- Conditions
- Depression, Suicide Risk
- Keywords
- Depression, Suicide, Ketamine, Neuroimaging, Treatment Resistant Depression, Natural History
- Medical subject headings
- Depression, Suicide, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Individuals who previously signed consent for ETPB research as healthy volunteers | |
| Mood Disorder Patients | Individuals with mood disorders who previously signed consent for ETPB research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Beck Depression Inventory (suicide item removed)
Rating of depression without assessment of suicidal ideation
Measured: Follow-up assessment
Secondary outcomes (3)
Ketamine utilization at non-NIH facility
Participants will report whether they accessed ketamine/esketamine after leaving NIH
Measured: Follow-up assessment
Self-reported suicide attempt
Self-reported suicide attempt since leaving NIH
Measured: Follow-up assessment
Identify predictors of death by suicide
Death as reported by the National Death Index (NDI)
Measured: Follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start17 Aug 2021
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elizabeth D Ballard, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877977
- Sponsor's protocol ID
- 10000375
- Other IDs
- 000375-M
- Status last verified
- 29 Sep 2026
- First submitted
- 6 May 2021
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical and demographic and biomarker participant data collected during the trial, after deidentification.
Publications
Gilbert JR, Ballard ED, Galiano CS, Nugent AC, Zarate CA Jr. Magnetoencephalographic Correlates of Suicidal Ideation in Major Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):354-363. doi: 10.1016/j.bpsc.2019.11.011. Epub 2019 Dec 3.
PubMed 31928949Ballard ED, Vande Voort JL, Bernert RA, Luckenbaugh DA, Richards EM, Niciu MJ, Furey ML, Duncan WC Jr, Zarate CA Jr. Nocturnal Wakefulness Is Associated With Next-Day Suicidal Ideation in Major Depressive Disorder and Bipolar Disorder. J Clin Psychiatry. 2016 Jun;77(6):825-31. doi: 10.4088/JCP.15m09943.
PubMed 27337418Nugent AC, Ballard ED, Gould TD, Park LT, Moaddel R, Brutsche NE, Zarate CA Jr. Ketamine has distinct electrophysiological and behavioral effects in depressed and healthy subjects. Mol Psychiatry. 2019 Jul;24(7):1040-1052. doi: 10.1038/s41380-018-0028-2. Epub 2018 Feb 27.
PubMed 29487402Hurst KT, Vogeley A, Greenstein DK, Durland L, Makel S, Wang PR, Yavi M, Zarate CA Jr, Ballard ED. Long-term follow-up of participants in ketamine clinical trials for mood disorders. J Affect Disord. 2024 Jul 15;357:134-137. doi: 10.1016/j.jad.2024.04.062. Epub 2024 Apr 22.
PubMed 38653350
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Observation of Participants With Mood Disorders
- ClinicalTrials.gov ID
- NCT04877977
- Acronym / sponsor ID
- 10000375
- Conditions
- Depression, Suicide Risk
- Keywords
- Depression, Suicide, Ketamine, Neuroimaging, Treatment Resistant Depression, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 year
Participant Duration: 20 minutes- 4 hours
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Individuals who previously signed consent for ETPB research as healthy volunteers |
| Mood Disorder Patients | – | –Individuals with mood disorders who previously signed consent for ETPB research |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study involves re-contacting former participants of 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers for participation in this follow-up study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score on Beck Depression Inventory (suicide item removed)
Time frame: Follow-up assessment
Rating of depression without assessment of suicidal ideation
3 secondary outcomes
Ketamine utilization at non-NIH facility
Time frame: Follow-up assessment
Self-reported suicide attempt
Time frame: Follow-up assessment
Identify predictors of death by suicide
Time frame: Follow-up assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 31928949Gilbert JR, Ballard ED, Galiano CS, Nugent AC, Zarate CA Jr. Magnetoencephalographic Correlates of Suicidal Ideation in Major Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):354-363. doi: 10.1016/j.bpsc.2019.11.011. Epub 2019 Dec 3.
- Background: PubMed 27337418Ballard ED, Vande Voort JL, Bernert RA, Luckenbaugh DA, Richards EM, Niciu MJ, Furey ML, Duncan WC Jr, Zarate CA Jr. Nocturnal Wakefulness Is Associated With Next-Day Suicidal Ideation in Major Depressive Disorder and Bipolar Disorder. J Clin Psychiatry. 2016 Jun;77(6):825-31. doi: 10.4088/JCP.15m09943.
- Background: PubMed 29487402Nugent AC, Ballard ED, Gould TD, Park LT, Moaddel R, Brutsche NE, Zarate CA Jr. Ketamine has distinct electrophysiological and behavioral effects in depressed and healthy subjects. Mol Psychiatry. 2019 Jul;24(7):1040-1052. doi: 10.1038/s41380-018-0028-2. Epub 2018 Feb 27.
- Derived from this study: PubMed 38653350Hurst KT, Vogeley A, Greenstein DK, Durland L, Makel S, Wang PR, Yavi M, Zarate CA Jr, Ballard ED. Long-term follow-up of participants in ketamine clinical trials for mood disorders. J Affect Disord. 2024 Jul 15;357:134-137. doi: 10.1016/j.jad.2024.04.062. Epub 2024 Apr 22.
- Individual participant dataSharing planned: Yes. Clinical and demographic and biomarker participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth D Ballard, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Suicide Risk, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth D Ballard, Ph.D. ((301) 435-9399, elizabeth.ballard@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Beck Depression Inventory (suicide item removed) (time frame: Follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04877977, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.