Major Depressive DisorderPhase 4NCT06644833
Effective of Transcranial Magnetic Stimulation (TMS) vs Treatment as Usual for First-Episode Depression in Adults
A Phase 4 study testing Transcranial magnetic stimulation and Antidepressant in people with Major Depressive Disorder, run by Sultan Qaboos University.
Trial summary
This clinical trial aims to assess the effectiveness of Transcranial Magnetic Stimulation (TMS) compared to Treatment as Usual (TAU) in adult patients experiencing their first or second episode of unipolar major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Transcranial magnetic stimulation and Antidepressant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jun 2029
- Phase
- Phase 4
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults (≥18 years old till 64 years) diagnosed with a first or second episode of unipolar major depressive disorder (MDD).
- Moderate to severe depressive symptoms based on clinical assessment and validated scales (e.g., Hamilton Depression Rating Scale (HDRS)).
- Willingness to participate and provide written informed consent.
- Outpatient setting (not currently hospitalized for psychiatric reasons).
Who cannot join
- Current episode is not the first or second episode of MDD.
- Substance dependence or abuse within the last 6 months.
- Diagnosed with psychotic depression, bipolar disorder, or catatonic features.
- Severe depression requiring electroconvulsive therapy (ECT).
- High suicidal risk as determined by clinical assessment.
- History of unsatisfactory responses to prior TMS treatments.
- Diagnosis of Epilepsy and Epilepsy high risk group
- Pregnant or breastfeeding women, unless cleared by a neurologist for TMS treatment.
About this study
Official title: Effectiveness of Transcranial Magnetic Stimulation (TMS) Versus Treatment as Usual for First-Episode Depression in Adult Patients. An Open-Label Randomised Controlled Trial
This clinical trial aims to assess the effectiveness of Transcranial Magnetic Stimulation (TMS) compared to Treatment as Usual (TAU) in adult patients experiencing their first or second episode of unipolar major depressive disorder (MDD). The primary end point is to determine whether TMS leads to higher rate of remission, response and greater reductions in depression severity, and improved functional outcomes compared to standard pharmacological and psychotherapeutic interventions. The trial will also explore the impact of TMS on quality of life and anxiety symptoms. Participants will be randomly assigned to either the TMS or TAU group, and outcomes will be assessed at multiple time points over a 3-year period. The trial will be conducted at Sultan Qaboos University Hospital's Department of Behavioural Medicine in Muscat, Oman, and is expected to contribute important evidence on the role of non-invasive brain stimulation in treating early-stage depression.
Read the detailed description
1.1. Background and Rationale First-episode depression (FED) comprises 50% of major depressive disorder (MDD) cases in the U.S. and contributes 80% of global disability due to mental and substance use disorders. Depression significantly impairs social and occupational functioning, ranking third among the leading causes of global disease burden for individuals aged 10-65. Untreated, FED may progress to chronic depression, addiction, and increased healthcare costs. Given the limitations of current antidepressant treatments, there is a growing need for alternative interventions, such as transcranial magnetic stimulation (TMS). TMS is a non-invasive, well-accepted therapy with emerging evidence of efficacy for depression, but its use in first-episode depression requires further research. This trial aims to compare the effectiveness of TMS versus Treatment as Usual (TAU) for adult FED patients.
1.2. Study Scope This open-label study will follow FED patients (≥18 years) with moderate or severe MDD in an outpatient setting. Exclusion criteria include substance abuse, psychotic or catatonic features, suicidal risk, or previous ineffective TMS treatment. Pregnant or breastfeeding women can participate with neurologist approval. Primary outcomes will measure depression severity and functional impairment, assessed at baseline and at four key follow-up points.
- Methodology A randomized controlled trial (RCT) will assess the comparative effectiveness of TMS and TAU. Participants will be randomly assigned to receive either TMS or TAU, with depression severity measured by standardized scales such as the Hamilton Depression Rating Scale (HAMD-24) and the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0). Baseline data and follow-up assessments will evaluate the impact of treatment on depressive symptoms, quality of life, and functional outcomes.
2.1. Study Design The study will recruit adult patients experiencing their first episode of MDD. Inclusion and exclusion criteria will ensure a homogenous sample. Participants will provide written informed consent and undergo baseline assessments before randomization into either the TMS or TAU group. TMS will be administered by trained operators using a standardized protocol. Follow-up will occur over six months, with assessments of depressive symptoms, functional outcomes, and quality of life at regular intervals.
2.2. Interventions Participants in the TMS group will receive 10 Hz stimulation at 120% motor threshold for ≤30 minutes per session. The TAU group will follow standard pharmacological and psychotherapeutic management. Safety measures include constant monitoring during TMS sessions, with anxiety management protocols in place.
- Conditions
- Major Depressive Disorder
- Being tested
- Transcranial magnetic stimulation, Antidepressant
- Keywords
- Transcranial Magnetic Stimulation,, Antidepressants, iTMS, 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.
Transcranial magnetic stimulationDevice
Transcranial Magnetic Stimulation (rTMS) sessions, targeting the dorsolateral prefrontal cortex, at a frequency of 10 Hz. Each session will last approximately 30 minutes, with 5 sessions per week for 4 to 6 weeks.
AntidepressantDrug
Selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, SNRIs
| Study group | Role | What they receive |
|---|---|---|
| Transcranial magnetic stimulation | Experimental | Participants will receive repetitive Transcranial Magnetic Stimulation (rTMS) sessions, targeting the dorsolateral prefrontal cortex, at a frequency of 10 Hz. Each session will last approximately 30 minutes, with 5 sessions per week for 4 to 6 weeks. TMS will be administered by certified professionals, and patients will be monitored for any adverse events during each session. Follow-up evaluations will occur at regular intervals over the 3-year study period. Receives: Device: Transcranial magnetic stimulation |
| Treatment as usual | Active comparator | Participants in this group will continue receiving standard care, which includes pharmacological management and psychotherapy based on clinical standards for MDD. Common medications may include selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, with dose adjustments made based on clinical response. Psychotherapy will involve cognitive-behavioral therapy or supportive therapy sessions as determined by the attending psychiatrist. Receives: Drug: Antidepressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission and Response rates between the two arms
Hamilton Depression Rating Scale (HDRS) The Hamilton Depression Rating Scale (HDRS) is a clinician-administered questionnaire commonly used to assess the severity of depression. It consists of 17 to 21 items, depending on the version used. Each item is scored on a scale from 0 to 2 or 0 to 4, with higher scores indicating more severe depression.
Minimum Score: 0
Maximum Score: 52 (for the 17-item version) or 64 (for the 21-item version)
Interpretation: Higher scores reflect greater severity of depressive symptoms, with cut-offs typically used to classify depression as mild, moderate, severe, or very severe.
Measured: 6 weeks
Remission and Response rates between the two arms
Patient Health Questionnaire-9 (PHQ-9) The PHQ-9 is a self-administered scale used to assess the severity of depression. It consists of 9 items that correspond to the diagnostic criteria for major depressive disorder (MDD) in the DSM-5. Each item is scored from 0 ("Not at all") to 3 ("Nearly every day").
Minimum Score: 0
Maximum Score: 27
Interpretation: Higher scores indicate more severe depressive symptoms. Scores are often interpreted as follows:
0-4: None to minimal depression
5-9: Mild depression
10-14: Moderate depression
15-19: Moderately severe depression
20-27: Severe depression
Measured: 6 weeks
Remission and Response rates between the two arms
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) The QIDS-SR is a brief, 16-item self-report questionnaire designed to assess the severity of depressive symptoms over the past week. Each item is scored on a scale from 0 to 3.
Minimum Score: 0
Maximum Score: 27
Interpretation: Higher scores indicate more severe depression. Scores are typically classified as:
0-5: Normal (no depression)
6-10: Mild depression
11-15: Moderate depression
16-20: Severe depression
21-27: Very severe depression
Measured: 6 weeks
Secondary outcomes (2)
Change in the Means Scores between the two arms at the end of the study of the GAD-7 andWHO-DAS 2.0)
---
WHO Disability Assessment Schedule (WHO-DAS 2.0) - 12-item Version The WHO-DAS 2.0 is a tool developed by the World Health Organization to measure health and disability across six domains: cognition, mobility, self-care, getting along with others, life activities, and participation in society. The 12-item version is a shortened version of the 36-item scale, designed for easier use while still covering the key aspects of disability. Each item is scored on a scale from 1 ("None") to 5 ("Extreme or cannot do").
Minimum Score: 12
Maximum Score: 60
Interpretation: Higher scores indicate greater levels of disability. The total score can also be converted to a percentage (0-100), with higher percentages reflecting greater disability. This version provides a quick overview of an individual's level of functioning across multiple domains.
---
Measured: 6 weeks
Change in the Means Scores between the two arms at the end of the study of the GAD-7 andWHO-DAS 2.0)
Generalized Anxiety Disorder-7 (GAD-7) The GAD-7 is a brief, self-report questionnaire used to assess the severity of generalized anxiety disorder (GAD). It consists of 7 items that ask respondents to rate how often they have been bothered by various anxiety symptoms over the past two weeks. Each item is scored from 0 ("Not at all") to 3 ("Nearly every day").
Minimum Score: 0
Maximum Score: 21
Interpretation: Higher scores indicate more severe anxiety. Scores are typically classified as follows:
0-4: Minimal anxiety
5-9: Mild anxiety
10-14: Moderate anxiety
15-21: Severe anxiety
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Al Alawi MD PhD MRCPsych ARABpsych OMSBpsych, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644833
- Sponsor's protocol ID
- 135
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcranial Magnetic Stimulation (TMS) Versus Treatment as Usual for First-Episode Depression in Adult Patients. An Open-Label Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06644833
- Acronym / sponsor ID
- 135
- Conditions
- Major Depressive Disorder
- Keywords
- Transcranial Magnetic Stimulation,, Antidepressants, iTMS, rTMS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 16 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.
This clinical trial aims to assess the effectiveness of Transcranial Magnetic Stimulation (TMS) compared to Treatment as Usual (TAU) in adult patients experiencing their first or second episode of unipolar major depressive disorder (MDD). The primary end point is to determine whether TMS leads to higher rate of remission, response and greater reductions in depression severity, and improved functional outcomes compared to standard pharmacological and psychotherapeutic interventions. The trial will also explore the impact of TMS on quality of life and anxiety symptoms. Participants will be randomly assigned to either the TMS or TAU group, and outcomes will be assessed at multiple time points over a 3-year period. The trial will be conducted at Sultan Qaboos University Hospital's Department of Behavioural Medicine in Muscat, Oman, and is expected to contribute important evidence on the role of non-invasive brain stimulation in treating early-stage depression.
Detailed description
1.1. Background and Rationale First-episode depression (FED) comprises 50% of major depressive disorder (MDD) cases in the U.S. and contributes 80% of global disability due to mental and substance use disorders. Depression significantly impairs social and occupational functioning, ranking third among the leading causes of global disease burden for individuals aged 10-65. Untreated, FED may progress to chronic depression, addiction, and increased healthcare costs. Given the limitations of current antidepressant treatments, there is a growing need for alternative interventions, such as transcranial magnetic stimulation (TMS). TMS is a non-invasive, well-accepted therapy with emerging evidence of efficacy for depression, but its use in first-episode depression requires further research. This trial aims to compare the effectiveness of TMS versus Treatment as Usual (TAU) for adult FED patients.
1.2. Study Scope This open-label study will follow FED patients (≥18 years) with moderate or severe MDD in an outpatient setting. Exclusion criteria include substance abuse, psychotic or catatonic features, suicidal risk, or previous ineffective TMS treatment. Pregnant or breastfeeding women can participate with neurologist approval. Primary outcomes will measure depression severity and functional impairment, assessed at baseline and at four key follow-up points.
- Methodology A randomized controlled trial (RCT) will assess the comparative effectiveness of TMS and TAU. Participants will be randomly assigned to receive either TMS or TAU, with depression severity measured by standardized scales such as the Hamilton Depression Rating Scale (HAMD-24) and the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0). Baseline data and follow-up assessments will evaluate the impact of treatment on depressive symptoms, quality of life, and functional outcomes.
2.1. Study Design The study will recruit adult patients experiencing their first episode of MDD. Inclusion and exclusion criteria will ensure a homogenous sample. Participants will provide written informed consent and undergo baseline assessments before randomization into either the TMS or TAU group. TMS will be administered by trained operators using a standardized protocol. Follow-up will occur over six months, with assessments of depressive symptoms, functional outcomes, and quality of life at regular intervals.
2.2. Interventions Participants in the TMS group will receive 10 Hz stimulation at 120% motor threshold for ≤30 minutes per session. The TAU group will follow standard pharmacological and psychotherapeutic management. Safety measures include constant monitoring during TMS sessions, with anxiety management protocols in place.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial magnetic stimulation | Experimental | Device: Transcranial magnetic stimulationParticipants will receive repetitive Transcranial Magnetic Stimulation (rTMS) sessions, targeting the dorsolateral prefrontal cortex, at a frequency of 10 Hz. Each session will last approximately 30 minutes, with 5 sessions per week for 4 to 6 weeks. TMS will be administered by certified professionals, and patients will be monitored for any adverse events during each session. Follow-up evaluations will occur at regular intervals over the 3-year study period. |
| Treatment as usual | Active comparator | Drug: AntidepressantParticipants in this group will continue receiving standard care, which includes pharmacological management and psychotherapy based on clinical standards for MDD. Common medications may include selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, with dose adjustments made based on clinical response. Psychotherapy will involve cognitive-behavioral therapy or supportive therapy sessions as determined by the attending psychiatrist. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults (≥18 years old till 64 years) diagnosed with a first or second episode of unipolar major depressive disorder (MDD).
- Moderate to severe depressive symptoms based on clinical assessment and validated scales (e.g., Hamilton Depression Rating Scale (HDRS)).
- Willingness to participate and provide written informed consent.
- Outpatient setting (not currently hospitalized for psychiatric reasons).
Key exclusion criteria (8 listed)
- Current episode is not the first or second episode of MDD.
- Substance dependence or abuse within the last 6 months.
- Diagnosed with psychotic depression, bipolar disorder, or catatonic features.
- Severe depression requiring electroconvulsive therapy (ECT).
- High suicidal risk as determined by clinical assessment.
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 |
|---|---|---|
| Transcranial magnetic stimulationTranscranial Magnetic Stimulation (rTMS) sessions, targeting the dorsolateral prefrontal cortex, at a frequency of 10 Hz. Each session will last approximately 30 minutes, with 5 sessions per week for 4 to 6 weeks. | Device | Transcranial magnetic stimulation |
| AntidepressantSelective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, SNRIs | Drug | Treatment as usual |
Primary outcome
Remission and Response rates between the two arms
Time frame: 6 weeks
Hamilton Depression Rating Scale (HDRS) The Hamilton Depression Rating Scale (HDRS) is a clinician-administered questionnaire commonly used to assess the severity of depression. It consists of 17 to 21 items, depending on the version used. Each item is scored on a scale from 0 to 2 or 0 to 4, with higher scores indicating more severe depression. Minimum Score: 0 Maximum Score: 52 (for the 17-item version) or 64 (for the 21-item version) Interpretation: Higher scores reflect greater severity of depressive symptoms, with cut-offs typically used to classify depression as mild, moderate, severe, or very severe.
Remission and Response rates between the two arms
Time frame: 6 weeks
Patient Health Questionnaire-9 (PHQ-9) The PHQ-9 is a self-administered scale used to assess the severity of depression. It consists of 9 items that correspond to the diagnostic criteria for major depressive disorder (MDD) in the DSM-5. Each item is scored from 0 ("Not at all") to 3 ("Nearly every day"). Minimum Score: 0 Maximum Score: 27 Interpretation: Higher scores indicate more severe depressive symptoms. Scores are often interpreted as follows: 0-4: None to minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression
Remission and Response rates between the two arms
Time frame: 6 weeks
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) The QIDS-SR is a brief, 16-item self-report questionnaire designed to assess the severity of depressive symptoms over the past week. Each item is scored on a scale from 0 to 3. Minimum Score: 0 Maximum Score: 27 Interpretation: Higher scores indicate more severe depression. Scores are typically classified as: 0-5: Normal (no depression) 6-10: Mild depression 11-15: Moderate depression 16-20: Severe depression 21-27: Very severe depression
2 secondary outcomes
Change in the Means Scores between the two arms at the end of the study of the GAD-7 andWHO-DAS 2.0)
Time frame: 6 weeks
Change in the Means Scores between the two arms at the end of the study of the GAD-7 andWHO-DAS 2.0)
Time frame: 6 weeks
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 28 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transcranial magnetic stimulation and Antidepressant in people with Major Depressive Disorder, run by Sultan Qaboos University.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Remission and Response rates between the two arms (time frame: 6 weeks). 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?
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 28 Oct 2024.