DepressionNCT03175887
Investigational TMS Treatment for Depression
A study testing TMS in people with Depression and Treatment Resistant Depression, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial summary
This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation at the forehead versus the left side of the head for treatment of Treatment Resistant Depression. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Treatment Resistant Depression
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2021to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21-70 years old
- inadequate response to one current antidepressant medication
- currently depressed
Who cannot join
- psychiatric comorbidities
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Junction VA Medical Center
White River Junction, Vermont, 05009
About this study
Official title: Dorsolateral Versus Medial Prefrontal TMS for Depression
This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation at the forehead versus the left side of the head for treatment of Treatment Resistant Depression.
Read the detailed description
While transcranial magnetic stimulation (TMS) to the left dorsolateral prefrontal cortex (DLPFC) is an FDA approved treatment for depression, a growing and converging database suggests the medial prefrontal cortex (MPFC) may be even more critical to the neurobiology of depression and antidepressant treatment response. This study will compare the efficacy of high frequency transcranial madntic stimulation on these two sections of the brain.
- Conditions
- Depression, Treatment Resistant Depression
- Being tested
- TMS
- Keywords
- depression, trd, treatment-resistant depression, TMS
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will receive TMS. They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex. Receives: Device: TMS |
| Treatment Arm | Other | After the experimental arm, if a patient was randomized to the medial prefrontal cortex during the experimental arm and it did not work for them, they have the option of returning for a session of TMS to the FDA-approved dorsolateral prefrontal cortex.
If they were assigned to the dorsolateral prefrontal cortex, they are not eligible to return for another set of treatment. Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale.
Measured: Change from baseline Hamilton-17 score to follow-up visit at 1 week after final TMS intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study startSep 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: PI's discretion due to needing to modify study protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Holtzheimer, White River Junction Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175887
- Sponsor's protocol ID
- D17107
- Status last verified
- May 2021
- First submitted
- 3 May 2017
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dorsolateral Versus Medial Prefrontal TMS for Depression
- ClinicalTrials.gov ID
- NCT03175887
- Acronym / sponsor ID
- D17107
- Conditions
- Depression, Treatment Resistant Depression
- Keywords
- depression, trd, treatment-resistant depression, TMS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI's discretion due to needing to modify study protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Study start
- Sep 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 5 Jun 2017 (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.
This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation at the forehead versus the left side of the head for treatment of Treatment Resistant Depression.
Detailed description
While transcranial magnetic stimulation (TMS) to the left dorsolateral prefrontal cortex (DLPFC) is an FDA approved treatment for depression, a growing and converging database suggests the medial prefrontal cortex (MPFC) may be even more critical to the neurobiology of depression and antidepressant treatment response. This study will compare the efficacy of high frequency transcranial madntic stimulation on these two sections of the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: TMSParticipants will receive TMS. They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex. |
| Treatment Arm | Other | Device: TMSAfter the experimental arm, if a patient was randomized to the medial prefrontal cortex during the experimental arm and it did not work for them, they have the option of returning for a session of TMS to the FDA-approved dorsolateral prefrontal cortex. If they were assigned to the dorsolateral prefrontal cortex, they are not eligible to return for another set of treatment. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 21-70 years old
- inadequate response to one current antidepressant medication
- currently depressed
Key exclusion criteria (1 listed)
- psychiatric comorbidities
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 |
|---|---|---|
| TMSTranscranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. | Device | Intervention Arm, Treatment Arm |
Primary outcome
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
Time frame: Change from baseline Hamilton-17 score to follow-up visit at 1 week after final TMS intervention.
Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Depression and Treatment Resistant Depression, run by White River Junction Veterans Affairs Medical Center 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 3 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: withdrawn, as of the sponsor's last update on 13 May 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (time frame: Change from baseline Hamilton-17 score to follow-up visit at 1 week after final TMS intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2021.