Major DepressionNCT04575285
Using EEG to Predict Depression Treatment Response to rTMS in Patients With Major Depression
An observational study of Major Depression and Repetitive Transcranial Magnetic Stimulation, run by Baptist Health South Florida at 1 site in United States.
Trial summary
Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. The study is looking at changes in specific electroencephalogram parameters in depressed patients treated with rTMS can serve as predictors of depression treatment response among cancer patents undergoing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depression, Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- Electroencephalogram (EEG)
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2020to 1 Dec 2031
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will be treated for major depression using rTMS (according to standard care)
Who may be able to join
- Diagnosed with cancer
- Comorbid diagnosis of major depressive disorder
- Age ≥ 18 years
- Baseline Hamilton Depression Rating Scale (HDRS) score ≥ 18
- Failed one or more adequate antidepressant trials (including selective serotonin reuptake inhibitors or SSRIs, selective norepinephrine reuptake inhibitors or SNRIs, tricyclic antidepressants or TCAs). A failed treatment response may be due to lack of antidepressant efficacy or intolerable side effects.
Who cannot join
- History of seizure or epilepsy
- History of concussion
- History of bipolar disorder
- Comorbid psychotic disorder
- Primary brain tumor or metastasis to brain
- Active comorbid substance use disorder
Show all 10Show fewer
- History or current diagnosis of dementia
- Current pregnancy
- Unable to attend regular treatment sessions
- Any other condition in which a physician investigator feels may subject the participant to undue risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using EEG to Predict Depression Treatment Response to Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Major Depression
Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. The study is looking at changes in specific electroencephalogram parameters in depressed patients treated with rTMS can serve as predictors of depression treatment response among cancer patents undergoing rTMS treatment of depression.
Read the detailed description
The study will be a prospective, single arm trial in which a set of patients who will be treated for major depression using Repetitive Transcranial Magnetic Stimulation (according to FDA approved rTMS standard care practices) also will undergo EEG recording before Repetitive Transcranial Magnetic Stimulation treatment begins, and at the completion of treatment. The Hamilton Depression Rating Scale will be given to participants by the neuropsychiatrist at baseline and weekly intervals till the completion of treatment.
The neuropsychiatrist investigators expect to see about 12 patients per year who meet treatment criteria for Repetitive Transcranial Magnetic Stimulation. Therefore, it is expected to recruit 24 subjects into the research study over a two-year period.
- Being tested
- Electroencephalogram (EEG)
- Keywords
- rTMS
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalogram (EEG)Diagnostic test
EEG measures brain activity by recording the spontaneous brain electrical activity and evoked responses non-invasively from the scalp. Reusable Tangle Free 10mm EEG Cup Electrodes will be placed on the subject's scalp using the 10-20 system montage.
| Study group | Role | What they receive |
|---|---|---|
| Electroencephalogram (EEG) | All participants will undergo EEG recording at baseline and end of treatment for a duration of 10-20 minutes per session. Receives: Diagnostic Test: Electroencephalogram (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale score
Hamilton Depression Rating Scale is used to measure severity of depression on a scale from 0 (no depression) to 52 (most severe depression).
Measured: baseline, and weekly until study completion, which can be up to 6 weeks
Secondary outcomes (1)
Electroencephalograph (EEG) scalp signal changes over time
Change in brain activity as measured by the EEG in microvolts.Scalp EEG signals will be processed in order to compare EEG brain connectivity and Frontal alpha asymmetry index (FAA).
Measured: baseline, end of treatment, which can be up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study startApr 2020 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2031 (estimated)
Why it stopped: Study was closed due to lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida International University
- Responsible party
- Sponsor
- Investigators
- Geetha Nampiaparampil, MD, Principal investigator, Miami Cancer Institute (MCI) at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575285
- Sponsor's protocol ID
- TMS Depression
- Status last verified
- Mar 2022
- First submitted
- 22 Sep 2020
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using EEG to Predict Depression Treatment Response to Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Major Depression
- ClinicalTrials.gov ID
- NCT04575285
- Acronym / sponsor ID
- TMS Depression
- Keywords
- rTMS
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was closed due to lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- Florida International University
- Study start
- Apr 2020 (estimated)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 5 Oct 2020 (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.
Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. The study is looking at changes in specific electroencephalogram parameters in depressed patients treated with rTMS can serve as predictors of depression treatment response among cancer patents undergoing rTMS treatment of depression.
Detailed description
The study will be a prospective, single arm trial in which a set of patients who will be treated for major depression using Repetitive Transcranial Magnetic Stimulation (according to FDA approved rTMS standard care practices) also will undergo EEG recording before Repetitive Transcranial Magnetic Stimulation treatment begins, and at the completion of treatment. The Hamilton Depression Rating Scale will be given to participants by the neuropsychiatrist at baseline and weekly intervals till the completion of treatment.
The neuropsychiatrist investigators expect to see about 12 patients per year who meet treatment criteria for Repetitive Transcranial Magnetic Stimulation. Therefore, it is expected to recruit 24 subjects into the research study over a two-year period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electroencephalogram (EEG) | – | Diagnostic Test: Electroencephalogram (EEG)All participants will undergo EEG recording at baseline and end of treatment for a duration of 10-20 minutes per session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be treated for major depression using rTMS (according to standard care)
Key inclusion criteria (5 listed)
- Diagnosed with cancer
- Comorbid diagnosis of major depressive disorder
- Age ≥ 18 years
- Baseline Hamilton Depression Rating Scale (HDRS) score ≥ 18
- Failed one or more adequate antidepressant trials (including selective serotonin reuptake inhibitors or SSRIs, selective norepinephrine reuptake inhibitors or SNRIs, tricyclic antidepressants or TCAs). A failed treatment response may be due to lack of antidepressant efficacy or intolerable side effects.
Key exclusion criteria (10 listed)
- History of seizure or epilepsy
- History of concussion
- History of bipolar disorder
- Comorbid psychotic disorder
- Primary brain tumor or metastasis to brain
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 |
|---|---|---|
| Electroencephalogram (EEG)EEG measures brain activity by recording the spontaneous brain electrical activity and evoked responses non-invasively from the scalp. Reusable Tangle Free 10mm EEG Cup Electrodes will be placed on the subject's scalp using the 10-20 system montage. | Diagnostic test | Electroencephalogram (EEG) |
Primary outcome
Change in Hamilton Depression Rating Scale score
Time frame: baseline, and weekly until study completion, which can be up to 6 weeks
Hamilton Depression Rating Scale is used to measure severity of depression on a scale from 0 (no depression) to 52 (most severe depression).
1 secondary outcome
Electroencephalograph (EEG) scalp signal changes over time
Time frame: baseline, end of treatment, which can be up to 6 weeks
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 25 Jun 2024.
- Miami Neuroscience InstituteLink provided by the sponsor.
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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.
Geetha Nampiaparampil, MD principal investigator
Miami Cancer Institute (MCI) at Baptist Health, Inc.
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 Major Depression and Repetitive Transcranial Magnetic Stimulation, run by Baptist Health South Florida 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 10 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 25 Jun 2024. 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?
Change in Hamilton Depression Rating Scale score (time frame: baseline, and weekly until study completion, which can be up to 6 weeks). 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 25 Jun 2024.