Depression - Major Depressive DisorderPhase 1/2NCT06667180
Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels
A Phase 1/2 study testing Low-intensity TMS in people with Depression - Major Depressive Disorder and Transcranial Magnetic Stimulation, run by Universidad de Guanajuato at 1 site in Mexico.
Trial summary
The goal of this randomised clinical trial is to evaluate the effects of transcranial magnetic stimulation (TMS) on major depressive disorder (MDD) and on the levels of 5-hydroxyindoleacetic acid (5-HIAA) and brain-derived neurotrophic factor (BDNF). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Transcranial Magnetic Stimulation, Placebo
- What is being tested?
- Low-intensity TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 28 Oct 2024to 26 Aug 2025
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years.
- Both sexes.
- Those who have a diagnosis of MDD previously made by the treating psychiatrist (considering time since diagnosis and recurrence of episodes).
- Those who continue with their respective treatment and attend follow-up consultations at the health facility.
- Those who do not have a history of epilepsy, schizophrenia, neurosurgeries.
- Those who do not have metal plates anywhere in the skull, neck, chest and shoulder.
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- Those who do not use pacemakers.
- Those who do not take hormone substitutes.
- Those who agree to participate in the research.
Who cannot join
- Those who are pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
High Specialty Medical Unit No. 1, Bajío. Mexican Social Security Institute
León, Guanajuato, 37328
Blanca O Murillo Ortíz, PhD Medical Sciences, 4772522013, bomo907@hotmail.com
Olga E Escobar Florez, Master of Medical Sciences, +524773703795, oe.escobarflorez@ugto.mx
About this study
The goal of this randomised clinical trial is to evaluate the effects of transcranial magnetic stimulation (TMS) on major depressive disorder (MDD) and on the levels of 5-hydroxyindoleacetic acid (5-HIAA) and brain-derived neurotrophic factor (BDNF). TMS works to treat MDD by using low-intensity magnetic fields to modulate certain areas of the brain, activating them which can help improve the mood of those suffering from the disorder. Final metabolites of serotonin such as 5-HIAA and growth factors such as BDNF will also be studied before starting the intervention and at the end to check if there is a significant change in their concentration. Likewise, its safety will be evaluated by monitoring the symptoms that they present at the end of the intervention and one month later. The main questions that are intended to be answered are:
- Does low-intensity TMS reduce depressive symptoms in patients with MDD?
- Does low-intensity TMS significantly change the initial and final concentrations of 5-HIAA and BDNF?
- What adverse effects might patients who are exposed to low-intensity TMS experience? The researchers will compare low-intensity and accelerated TMS with sham TMS to see if low-intensity TMS works to treat MDD.
Read more
Participants:
- Will undergo an initial clinical assessment to confirm the disorder, comorbidities, and general health status.
- A 5 mL blood sample will be taken before starting the intervention.
- Low-intensity TMS will be applied for 4 days, 5 daily sessions of 200 s with 10-minute intersession intervals at a field intensity of 2-4 milliTesla (mT) and frequency of 50 Hz in theta bursts. Symptoms will be monitored daily.
- A 5 mL blood sample will be taken at the end of the intervention and general health status clinimetrics will be reapplied.
- Being tested
- Low-intensity TMS, Transcranial Magnetic Stimulation Sham
- Keywords
- accelerated low-intensity transcranial magnetic stimulation, Major depressive disorder, depression, brain-derived neurotrophic factor, 5-hydroxyindoleacetic acid
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity TMSDevice
Low-intensity TMS will be applied for 4 days, 5 daily sessions of 200 s with 10-minute intersession intervals at a field intensity of 2-4 mT and frequency of 50 Hz in theta bursts.
Transcranial Magnetic Stimulation ShamDevice
The control group will receive the simulation of low-intensity TMS without magnetic field induction.
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity TMS | Experimental | This group will receive the real low-intensity TMS Receives: Device: Low-intensity TMS |
| Sham low-intensity TMS | Placebo comparator | This group will receive the simulation of the low-intensity TMS Receives: Device: Transcranial Magnetic Stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in symptoms of depression
Improvement in depression symptoms, assessed by the Hamilton Depression Rating Scale (HAM-D17) which measures the severity of depression symptoms.
Measured: From admission until the end of the 4 days of intervention and one month after the end of the intervention
Secondary outcomes (1)
Changes in serum concentrations of 5-HIAA and BDNF
5-HIAA and BDNF are neurochemical biomarkers that may correlate with response to depression treatment.
Measured: From admission until the end of the 4 days of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start28 Oct 2024
- Primary completion30 May 2025 (estimated)
- Study completion26 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Principal investigator, Olga Estefania Escobar Florez, Universidad de Guanajuato
- Investigators
- Ma. Eugenia Garay Sevilla, PhD in medical sciences, Study director, Universidad de GuanajuatoJosé M De la Roca Chiapas, PhD in medical sciences, Study director, Universidad de GuanajuatoBlanca O Murillo Ortíz, PhD in medical sciences, Study director, Universidad de GuanajuatoAngélica Hernández Rayas, Physics PhD, Study chair, Universidad de GuanajuatoOlga E Escobar Florez, Master of Medical Sciences, Principal investigator, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667180
- Sponsor's protocol ID
- CEPIUG-P35-2023
- Other IDs
- R-2024-785-001
- Status last verified
- May 2025
- First submitted
- 28 Oct 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) information will not be shared to ensure the privacy and confidentiality of participants, sharing IPD could expose participants to additional risks of identification, for these reasons, and to protect the rights and confidentiality of participants, we have decided not to share IPD in this study.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels
- ClinicalTrials.gov ID
- NCT06667180
- Acronym / sponsor ID
- CEPIUG-P35-2023
- Keywords
- accelerated low-intensity transcranial magnetic stimulation, Major depressive disorder, depression, brain-derived neurotrophic factor, 5-hydroxyindoleacetic acid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 26 Aug 2025 (estimated)
- First posted
- 31 Oct 2024 (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.
The goal of this randomised clinical trial is to evaluate the effects of transcranial magnetic stimulation (TMS) on major depressive disorder (MDD) and on the levels of 5-hydroxyindoleacetic acid (5-HIAA) and brain-derived neurotrophic factor (BDNF). TMS works to treat MDD by using low-intensity magnetic fields to modulate certain areas of the brain, activating them which can help improve the mood of those suffering from the disorder. Final metabolites of serotonin such as 5-HIAA and growth factors such as BDNF will also be studied before starting the intervention and at the end to check if there is a significant change in their concentration. Likewise, its safety will be evaluated by monitoring the symptoms that they present at the end of the intervention and one month later. The main questions that are intended to be answered are:
- Does low-intensity TMS reduce depressive symptoms in patients with MDD?
- Does low-intensity TMS significantly change the initial and final concentrations of 5-HIAA and BDNF?
- What adverse effects might patients who are exposed to low-intensity TMS experience? The researchers will compare low-intensity and accelerated TMS with sham TMS to see if low-intensity TMS works to treat MDD.
Participants:
- Will undergo an initial clinical assessment to confirm the disorder, comorbidities, and general health status.
- A 5 mL blood sample will be taken before starting the intervention.
- Low-intensity TMS will be applied for 4 days, 5 daily sessions of 200 s with 10-minute intersession intervals at a field intensity of 2-4 milliTesla (mT) and frequency of 50 Hz in theta bursts. Symptoms will be monitored daily.
- A 5 mL blood sample will be taken at the end of the intervention and general health status clinimetrics will be reapplied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-intensity TMS | Experimental | Device: Low-intensity TMSThis group will receive the real low-intensity TMS |
| Sham low-intensity TMS | Placebo comparator | Device: Transcranial Magnetic Stimulation ShamThis group will receive the simulation of the low-intensity TMS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age between 18 and 60 years.
- Both sexes.
- Those who have a diagnosis of MDD previously made by the treating psychiatrist (considering time since diagnosis and recurrence of episodes).
- Those who continue with their respective treatment and attend follow-up consultations at the health facility.
- Those who do not have a history of epilepsy, schizophrenia, neurosurgeries.
Key exclusion criteria (1 listed)
- Those who are pregnant.
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 |
|---|---|---|
| Low-intensity TMSLow-intensity TMS will be applied for 4 days, 5 daily sessions of 200 s with 10-minute intersession intervals at a field intensity of 2-4 mT and frequency of 50 Hz in theta bursts. | Device | Low-intensity TMS |
| Transcranial Magnetic Stimulation ShamThe control group will receive the simulation of low-intensity TMS without magnetic field induction. | Device | Sham low-intensity TMS |
Primary outcome
Improvement in symptoms of depression
Time frame: From admission until the end of the 4 days of intervention and one month after the end of the intervention
Improvement in depression symptoms, assessed by the Hamilton Depression Rating Scale (HAM-D17) which measures the severity of depression symptoms.
1 secondary outcome
Changes in serum concentrations of 5-HIAA and BDNF
Time frame: From admission until the end of the 4 days of intervention.
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 8 May 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) information will not be shared to ensure the privacy and confidentiality of participants, sharing IPD could expose participants to additional risks of identification, for these reasons, and to protect the rights and confidentiality of participants, we have decided not to share IPD in this study.
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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.
Ma. Eugenia Garay Sevilla, PhD in medical sciences study director
Universidad de Guanajuato
José M De la Roca Chiapas, PhD in medical sciences study director
Universidad de Guanajuato
Blanca O Murillo Ortíz, PhD in medical sciences study director
Universidad de Guanajuato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low-intensity TMS in people with Depression - Major Depressive Disorder and Transcranial Magnetic Stimulation, run by Universidad de Guanajuato at 1 site in Mexico.
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 9 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 8 May 2025. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Olga E Escobar Florez, Master of Medical Sciences (+524773703795, oe.escobarflorez@ugto.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in symptoms of depression (time frame: From admission until the end of the 4 days of intervention and one month after the end of the 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 8 May 2025.