Major Depressive Disorder (MDD)LiTMSNCT07638202
Transcranial Magnetic Stimulation in Depression.
A study testing The experimental group(A) received conventional drug treatment combined with Li-TMS. in people with Major Depressive Disorder (MDD), run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Major depressive disorder (MDD) has increased in recent years, affecting 16.1% of the adult population nationwide. Currently, there are pharmacological and psychological treatments that have a 67% remission rate for depressive symptoms and insomnia after up to four trials of antidepressant treatments. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- The experimental group(A) received conventional drug treatment combined with Li-TMS.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 6 Jan 2025to 18 May 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of major depressive disorder
- insomnia
Who cannot join
- Epilepsy
- Alzheimer's Disease
Trial locations and contacts
1 site in 1 country.
Mexico1 site
1Clinical Epidemiology Research Unit. OOAD Guanajuato. Mexican Social Security Institute, Leon, Mexico,
León, Guanajuato, 37328
About this study
Official title: Effect of Low-intensity Transcranial Magnetic Stimulation (Li-TMS) on Sleep Disorders, Inflammation Levels, and Brain-derived Neurotrophic Factor in Patients With Depression.
Major depressive disorder (MDD) has increased in recent years, affecting 16.1% of the adult population nationwide. Currently, there are pharmacological and psychological treatments that have a 67% remission rate for depressive symptoms and insomnia after up to four trials of antidepressant treatments. Recently, low-intensity transcranial magnetic stimulation (Li-TMS) has been used to activate and generate structural and neural functioning changes in specific cortical regions such as the left dorsolateral prefrontal cortex, as its activity is altered in MDD. Furthermore, an increase in circulating levels of granulocytes, monocytes, and inflammatory cytokines has been observed in patients with MDD, suggesting an association between inflammation and neurotoxicity with the development of depression and decreased BDNF, mainly affecting the prefrontal cortex and hippocampus. Therefore, it has been proposed to quantify markers of systemic inflammation and evaluate their correlation with MDD and their possible effect with Li-TMS. This was a probabilistic, two-arm, block-randomized, single-blind clinical trial. A qualified psychiatrist evaluated the patients according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) to confirm the diagnosis of major depressive disorder. Two groups were formed and randomly assigned to receive treatment: transcranial magnetic stimulation or the sham group. The patients were unaware of the treatment; they did not know whether they would receive low-intensity transcranial magnetic stimulation (Li-TMS) or not.
It was a clinical trial, two arms, probabilistic, block randomized, single-blind. The experimental group received conventional drug treatment combined with Li-TMS, and the control group was administered standard drug therapy with coil placement, without exposure to Li-TMS emission. Both groups had the device coils placed on them.
Read the detailed description
In low- and middle-income countries, only 25% of patients diagnosed with depression receive some form of treatment, with the current options being standard drug therapy and/or psychotherapy (WHO, 2023) (1). However, only about 35% of patients achieve complete remission of symptoms, resulting in more than half of patients with treatment-resistant depression (4).
Several studies have evaluated the efficacy of bilateral high-frequency (10 Hz) (5,6) and low-frequency (1 Hz) (50) Li-TMS applied to the dorsolateral prefrontal cortex (DLPFC) in patients with depression and insomnia over a 6-week period, totaling 30 sessions. These studies showed improvement in depressive symptoms and sleep quality in adults beginning at session 10 (5) and 15, respectively, as assessed by the Pittsburgh Sleep Quality Index (PSQI) and the Patient Health Questionnaire-9 (PHQ9) (7).
The exact mechanism by which Li-TMS improves sleep quality in patients with depression remains unclear. However, evidence indicates that patients who underwent high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) demonstrate improvement in sleep patterns, improvement in sleep stage, positive correlations in motor evoked potential, negative correlations with GABA and BDNF levels, as well as decreased levels of thyroid hormone, adrenocorticotropic hormone, and thyroid-stimulating hormone (5).
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- The experimental group(A) received conventional drug treatment combined with Li-TMS., control group B were administered standard drug therapy with coil placement, without exposure to Li-TMS emission.
- Keywords
- low-intensity transcranial magnetic stimulation, Major Depressive Disorder
- 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.
The experimental group(A) received conventional drug treatment combined with Li-TMS.Other
20 sessions of Li-TMS with the medical device Nibbot Pro Series. Each Li-TMS session consisted in positioning an eight-shaped coil over the left dorsolateral prefrontal cortex (L-DLPFC) which dispensed magnetic pulses at 25 Hz, (30 mT) for 45 minutes. Subjects received one Li-TMS session daily, from Monday through Friday. The experimental group received conventional drug treatment combined with Li-TMS, and the control group were administered standard drug therapy with coil placement, without exposure to Li-TMS emission. Both groups had the device coils placed on them. At the end of the study, the control group received Li-TMS treatment.
control group B were administered standard drug therapy with coil placement, without exposure to Li-TMS emission.Other
the control group were administered standard drug therapy with coil placement, without exposure to Li-TMS emission.
| Study group | Role | What they receive |
|---|---|---|
| group of sham-treated patients | Sham comparator | The Sham group was administered standard drug therapy with coil placement, without exposure to Li-TMS emission. Receives: Other: control group B were administered standard drug therapy with coil placement, without exposure to Li-TMS emission. |
| Group receive low-intensity transcranial magnetic stimulation (Li-TMS) | Active comparator | Group receive low-intensity transcranial magnetic stimulation (Li-TMS) Receives: Other: The experimental group(A) received conventional drug treatment combined with Li-TMS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depressive symptoms following 20 sessions of transcranial magnetic stimulation.
The Hamilton Scale assesses the severity of depression or anxiety using scores that classify symptoms as mild, moderate, or severe, consists of 17 items that assess aspects such as mood, anxiety, insomnia, loss of interest, and somatic symptoms. Each item is scored between 0 and 2 or 0 and 4, depending on the symptom. The total score is obtained by adding the values of all items, with a typical range of 0 to 52 points.
Interpretation of HAM-D Scores: 0-7 points: No depression. 8-13 points: Mild depression.14-18 points: Moderate depression 19-22 points: Severe depression >23 points: Very severe depression, with risk of suicide.
The scale also allows for monitoring changes in symptoms over time, evaluating response to treatment or remission of depression. A decrease of at least 50% from the initial score indicates a response to treatment, and scores below-7 suggest remission.
Measured: From the start of treatment until 4 weeks after it ends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start6 Jan 2025
- Primary completion25 Jul 2025
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Model description
- This was a probabilistic, two-arm, block-randomized, single-blind clinical trial. A qualified psychiatrist evaluated the patients according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) to confirm the diagnosis of major depressive disorder. Two groups were formed and randomly assigned to receive treatment: transcranial magnetic stimulation or the sham group. The patients were unaware of the treatment; they did not know whether they would receive low-intensity transcranial magnetic stimulation (Li-TMS) or not.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Blanca Olivia Murillo Ortiz, Instituto Mexicano del Seguro Social
- Investigators
- Blanca Olivia Murillo Ortiz, PhD, Principal investigator, Mexican Social Security Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638202
- Sponsor's protocol ID
- IMSS1
- Other IDs
- R-2024-785-075
- Acronym
- LiTMS
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be accessible in a properly anonymized form, as the confidential information is protected and cannot be used to identify participants. However, the results are available upon formal request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-intensity Transcranial Magnetic Stimulation (Li-TMS) on Sleep Disorders, Inflammation Levels, and Brain-derived Neurotrophic Factor in Patients With Depression.
- ClinicalTrials.gov ID
- NCT07638202
- Acronym / sponsor ID
- LiTMS / IMSS1
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- low-intensity transcranial magnetic stimulation, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 10 Jun 2026 (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.
Major depressive disorder (MDD) has increased in recent years, affecting 16.1% of the adult population nationwide. Currently, there are pharmacological and psychological treatments that have a 67% remission rate for depressive symptoms and insomnia after up to four trials of antidepressant treatments. Recently, low-intensity transcranial magnetic stimulation (Li-TMS) has been used to activate and generate structural and neural functioning changes in specific cortical regions such as the left dorsolateral prefrontal cortex, as its activity is altered in MDD. Furthermore, an increase in circulating levels of granulocytes, monocytes, and inflammatory cytokines has been observed in patients with MDD, suggesting an association between inflammation and neurotoxicity with the development of depression and decreased BDNF, mainly affecting the prefrontal cortex and hippocampus. Therefore, it has been proposed to quantify markers of systemic inflammation and evaluate their correlation with MDD and their possible effect with Li-TMS. This was a probabilistic, two-arm, block-randomized, single-blind clinical trial. A qualified psychiatrist evaluated the patients according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) to confirm the diagnosis of major depressive disorder. Two groups were formed and randomly assigned to receive treatment: transcranial magnetic stimulation or the sham group. The patients were unaware of the treatment; they did not know whether they would receive low-intensity transcranial magnetic stimulation (Li-TMS) or not.
It was a clinical trial, two arms, probabilistic, block randomized, single-blind. The experimental group received conventional drug treatment combined with Li-TMS, and the control group was administered standard drug therapy with coil placement, without exposure to Li-TMS emission. Both groups had the device coils placed on them.
Detailed description
In low- and middle-income countries, only 25% of patients diagnosed with depression receive some form of treatment, with the current options being standard drug therapy and/or psychotherapy (WHO, 2023) (1). However, only about 35% of patients achieve complete remission of symptoms, resulting in more than half of patients with treatment-resistant depression (4).
Several studies have evaluated the efficacy of bilateral high-frequency (10 Hz) (5,6) and low-frequency (1 Hz) (50) Li-TMS applied to the dorsolateral prefrontal cortex (DLPFC) in patients with depression and insomnia over a 6-week period, totaling 30 sessions. These studies showed improvement in depressive symptoms and sleep quality in adults beginning at session 10 (5) and 15, respectively, as assessed by the Pittsburgh Sleep Quality Index (PSQI) and the Patient Health Questionnaire-9 (PHQ9) (7).
The exact mechanism by which Li-TMS improves sleep quality in patients with depression remains unclear. However, evidence indicates that patients who underwent high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) demonstrate improvement in sleep patterns, improvement in sleep stage, positive correlations in motor evoked potential, negative correlations with GABA and BDNF levels, as well as decreased levels of thyroid hormone, adrenocorticotropic hormone, and thyroid-stimulating hormone (5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This was a probabilistic, two-arm, block-randomized, single-blind clinical trial. A qualified psychiatrist evaluated the patients according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) to confirm the diagnosis of major depressive disorder. Two groups were formed and randomly assigned to receive treatment: transcranial magnetic stimulation or the sham group. The patients were unaware of the treatment; they did not know whether they would receive low-intensity transcranial magnetic stimulation (Li-TMS) or not.
| Arm | Type | Receives |
|---|---|---|
| group of sham-treated patients | Sham comparator | Other: control group B were administered standard drug therapy with coil placement, without exposure to Li-TMS emission.The Sham group was administered standard drug therapy with coil placement, without exposure to Li-TMS emission. |
| Group receive low-intensity transcranial magnetic stimulation (Li-TMS) | Active comparator | Other: The experimental group(A) received conventional drug treatment combined with Li-TMS.Group receive low-intensity transcranial magnetic stimulation (Li-TMS) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of major depressive disorder
- insomnia
Key exclusion criteria (2 listed)
- Epilepsy
- Alzheimer's Disease
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 |
|---|---|---|
| The experimental group(A) received conventional drug treatment combined with Li-TMS.20 sessions of Li-TMS with the medical device Nibbot Pro Series. Each Li-TMS session consisted in positioning an eight-shaped coil over the left dorsolateral prefrontal cortex (L-DLPFC) which dispensed magnetic pulses at 25 Hz, (30 mT) for 45 minutes. Subjects received one Li-TMS session daily, from Monday through Friday. The experimental group received conventional drug treatment combined with Li-TMS, and the control group were administered standard drug therapy with coil placement, without exposure to Li-TMS emission. Both groups had the device coils placed on them. At the end of the study, the control group received Li-TMS treatment. | Other | Group receive low-intensity transcranial magnetic stimulation (Li-TMS) |
| control group B were administered standard drug therapy with coil placement, without exposure to Li-TMS emission.the control group were administered standard drug therapy with coil placement, without exposure to Li-TMS emission. | Other | group of sham-treated patients |
Primary outcome
Changes in depressive symptoms following 20 sessions of transcranial magnetic stimulation.
Time frame: From the start of treatment until 4 weeks after it ends.
The Hamilton Scale assesses the severity of depression or anxiety using scores that classify symptoms as mild, moderate, or severe, consists of 17 items that assess aspects such as mood, anxiety, insomnia, loss of interest, and somatic symptoms. Each item is scored between 0 and 2 or 0 and 4, depending on the symptom. The total score is obtained by adding the values of all items, with a typical range of 0 to 52 points. Interpretation of HAM-D Scores: 0-7 points: No depression. 8-13 points: Mild depression.14-18 points: Moderate depression 19-22 points: Severe depression >23 points: Very severe depression, with risk of suicide. The scale also allows for monitoring changes in symptoms over time, evaluating response to treatment or remission of depression. A decrease of at least 50% from the initial score indicates a response to treatment, and scores below-7 suggest remission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. The data will be accessible in a properly anonymized form, as the confidential information is protected and cannot be used to identify participants. However, the results are available upon formal request.
Related trials for Major Depressive Disorder (MDD)
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
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.
Blanca Olivia Murillo Ortiz, PhD principal investigator
Mexican Social Security Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The experimental group(A) received conventional drug treatment combined with Li-TMS. in people with Major Depressive Disorder (MDD), run by Instituto Mexicano del Seguro Social 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 2 inclusion and 2 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 10 Jun 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in depressive symptoms following 20 sessions of transcranial magnetic stimulation. (time frame: From the start of treatment until 4 weeks after it ends.). 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 10 Jun 2026.