MDDNCT04076644

Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder

A study testing TMS treatment in people with MDD, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: MDD
What is being tested?: TMS treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2019to 1 Sep 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must have recently (within 4 weeks) completed an acute TMS course (full 36 treatments) at the University of Missouri Columbia Neuromodulation clinic
Must have clinically responded to the acute TMS treatment course (≥50% improvement according to the clinical depressive scale used - usually the PHQ-9)
Must be able sign consent
Must have a current address and phone number
Must have current mental health care provider, either psychiatrist or general practioner who they see for mental health symptom management
Must be able to taper off antidepressant medication before 1st monthly treatment block (treatment group only)

Who cannot join

- Subject that has not completed a full acute treatment course, including taper
Subjects that have changed anything that may not make them safe for TMS, which are (all changes will be reviewed by study MD, and will not necessarily be excluded possibly depending on severity):
Any new metal near head
Any new medical devices that cannot be removed
Any new pregnancies (verbally confirmed)
Seizures that occurred post-acute TMS treatment

Show all 13Show fewer

Any uncontrolled cardiovascular disease
Any new head trauma
Any new illness causing injury to brain
Any new medications which cannot be altered or lowered that may be contraindicated for TMS treatment
Any drug or alcohol use deemed by the study doctor as unsafe for TMS treatment
Subjects unwilling to sign consent or follow study procedures
Subjects with known extended travel plans which may affect study procedures and scheduled TMS treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Missouri Neuromodulation Center
Columbia, Missouri, 65203

Other trials in United States

About this study

Official title: Maintenance of Response To Transcranial Magnetic Stimulation (TMS) in Major Depressive Disorder (MDD) Using Monthly TMS Treatment

This an open label study using a FDA-cleared TMS stimulation protocols which will be used to treat patients who have responded or remitted from depression using acute clinical TMS therapy at the University of Missouri-Columbia Neuromodulation Clinic. TMS therapy will be given to subjects at monthly intervals. Depression severity questionnaires will be given monthly to determine if the subjects original response to TMS can be maintained. Subjects will be tapered down from antidepressant medication prior to TMS maintenance treatment. Results will be analyzed to determine the effectiveness and feasibility of maintenance TMS therapies in a clinical setting.

Read the detailed description

This an open label study using Transcranial Magnetic Stimulation (TMS) as a maintenance treatment for subjects that have seen a clinically significant response or remission from their depressive symptoms after having had an acute clinical course of TMS. All potential subjects must have been treated at the University of Missouri Columbia Neuromodulation Clinic to qualify.

There are 2 arms in this study. The first is a group of patients who will not receive any TMS treatments and will be followed for a year, and have their depression severity assessed monthly using the Personal Health Questionnaire (PHQ9), and the Quick Inventory of Depressive Symptoms.

The second arm will receive TMS treatments 5 times/month for 12 months, be assessed for changes in depressive symptom severity monthly using the PHQ9 and QIDS. TMS treatment protocols will consist of wither the standard 20min 10Hz protocol, or a 3min theta-burst protocol. The protocol used will be determined by what worked for the subject when they were treated clinically at the University of Missouri Columbia Neuromodulation clinic. Subjects in this arm will be tapered of antidepressant medication prior to monthly TMS treatment and will remain antidepressant free for the duration of the study.

The study will be a year long in duration.

Conditions: MDD
Being tested: TMS treatment
Keywords: TMS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TMS treatmentDevice
Also called Transcranial Magnetic Stimulation
TMS using either a standard 10hz 20min or 3 min theta burst protocol

Study groups in NCT04076644
Study group	Role	What they receive
TMS Treatment Arm	Active comparator	Subjects will receive either a 20min 10hz TMS treatment, or a 3min theta-burst TMS treatment at certain monthly intervals. The TMS treatment protocol they receive depends on what they received in their acute clinical treatment. Subjects in the arm will be tapered off antidepressant medication before TMS treatment begins. Subjects will be assessed monthly for depression using QIDS and PHQ9. Receives: Device: TMS treatment
No TMS Arm	No intervention	Subjects will be followed and assessed for depressive symptoms at monthly time intervals similar to the active treatment arm using QIDS and PHQ9. This group does not receive TMS treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block, scale is 0-27 with 0=no depression, 27=severe depression
Measured: given at monthly intervals for 12 months
Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores
The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block (Pre Trt Month) and after every monthly TMS treatment block (Post Trt Month) ,scale is 0-27 with 0=no depression, 27=severe depression
Measured: given at baseline and before and after TMS treatment block for 12 months
Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores
The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block (Pre Trt Month) and after every monthly TMS treatment block (Post Trt Month) ,scale is 0-27 with 0=no depression, 27=severe depression
Measured: given at baseline and before and after each TMS treatment block for 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20191 Sep 2021

First posted3 Sep 2019
Study start1 Sep 2019
Primary completion1 Sep 2021
Study completion1 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MDDStudies of the same condition, open and under way.
More trials run by University of Missouri-ColumbiaThe 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04076644
Sponsor's protocol ID: 2013884
Status last verified: Dec 2022
First submitted: 23 Aug 2019
Last updated: 4 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Maintenance of Response To Transcranial Magnetic Stimulation (TMS) in Major Depressive Disorder (MDD) Using Monthly TMS Treatment
ClinicalTrials.gov ID: NCT04076644
Acronym / sponsor ID: 2013884
Conditions: MDD
Keywords: TMS
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Study start: 1 Sep 2019 (actual)
Primary completion: 1 Sep 2021 (actual)
Study completion: 1 Sep 2021 (actual)
First posted: 3 Sep 2019 (actual)
Results: Posted 4 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will be a year long in duration.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TMS Treatment Arm	Active comparator	Device: TMS treatmentSubjects will receive either a 20min 10hz TMS treatment, or a 3min theta-burst TMS treatment at certain monthly intervals. The TMS treatment protocol they receive depends on what they received in their acute clinical treatment. Subjects in the arm will be tapered off antidepressant medication before TMS treatment begins. Subjects will be assessed monthly for depression using QIDS and PHQ9.
No TMS Arm	No intervention	–Subjects will be followed and assessed for depressive symptoms at monthly time intervals similar to the active treatment arm using QIDS and PHQ9. This group does not receive TMS treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Must have recently (within 4 weeks) completed an acute TMS course (full 36 treatments) at the University of Missouri Columbia Neuromodulation clinic
Must have clinically responded to the acute TMS treatment course (≥50% improvement according to the clinical depressive scale used - usually the PHQ-9)
Must be able sign consent
Must have a current address and phone number
Must have current mental health care provider, either psychiatrist or general practioner who they see for mental health symptom management

Key exclusion criteria (13 listed)

- Subject that has not completed a full acute treatment course, including taper
Subjects that have changed anything that may not make them safe for TMS, which are (all changes will be reviewed by study MD, and will not necessarily be excluded possibly depending on severity):
Subjects unwilling to sign consent or follow study procedures
Subjects with known extended travel plans which may affect study procedures and scheduled TMS treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TMS treatmentAlso: Transcranial Magnetic StimulationTMS using either a standard 10hz 20min or 3 min theta burst protocol	Device	TMS Treatment Arm

Primary outcome

Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Time frame: given at monthly intervals for 12 months
The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block, scale is 0-27 with 0=no depression, 27=severe depression
Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores
Time frame: given at baseline and before and after TMS treatment block for 12 months
The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block (Pre Trt Month) and after every monthly TMS treatment block (Post Trt Month) ,scale is 0-27 with 0=no depression, 27=severe depression
Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores
Time frame: given at baseline and before and after each TMS treatment block for 12 months
The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block (Pre Trt Month) and after every monthly TMS treatment block (Post Trt Month) ,scale is 0-27 with 0=no depression, 27=severe depression

Results and safety

Results posted to the registry on 4 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TMS Treatment Arm	11	7

Primary outcome: Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)

Time frame: given at monthly intervals for 12 months. Mean (Standard Deviation). Unit: score on a scale

Measure	TMS Treatment Arm n = 7
Baseline (prior to starting treatment)	5 (4.04)
Month 1	6.71 (3.05)
Month 2	8.14 (3.18)
Month 3	9.14 (4.67)
Month 4	6.14 (4.22)
Month 5	7.57 (6.06)
Month 6	5.85 (3.09)
Month 7	5.71 (3.49)

Primary outcome: Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores

Time frame: given at baseline and before and after TMS treatment block for 12 months. Mean (Standard Deviation). Unit: score on a scale

Measure	TMS Treatment Arm n = 7
Baseline	4.14 (2.36)
Pre Trt Month 1	7.57 (3.33)
Pre Trt Month 2	8.86 (4.09)
Pre Trt Month 3	8.43 (4.27)
Pre Trt Month 4	6.86 (4.55)
Pre Trt Month 5	8.86 (5.67)
Pre Trt Month 6	7 (6.07)
Pre Trt Month 7	5.43 (2.82)

Primary outcome: Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores

Time frame: given at baseline and before and after each TMS treatment block for 12 months. Mean (Standard Deviation). Unit: score on a scale

Measure	TMS Treatment Arm n = 7
Baseline	4.14 (2.36)
Post Trt Month 1	6.29 (2.60)
Post Trt Month 2	6 (2.39)
Post Trt Month 3	5.43 (2.44)
Post Trt Month 4	4.55 (4.06)
Post Trt Month 5	6.14 (3.72)
Post Trt Month 6	4.71 (3.88)
Post Trt Month 7	5 (2.53)

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TMS Treatment Arm	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Due to changes in staff and start of COVID our recruitment was limited. Orginally a non-TMS treatment arm was planned but due to COVID we were unable to recruit for this arm.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Muaid Ithman, MD principal investigator

University of Missouri-Columbia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TMS treatment in people with MDD, run by University of Missouri-Columbia 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 4 Jan 2023. 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?

Yes. Results are posted in the registry (first posted 4 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) (time frame: given at monthly intervals for 12 months). The study lists 3 primary outcomes in all. 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 NCT04076644.

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 4 Jan 2023.