Effective of Transcranial Magnetic Stimulation (TMS) vs Treatment as Usual for First-Episode Depression in Adults

NCT06644833 | Not Yet Recruiting Phase 4 DMC FDA Device

• 1 other identifier: 135
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Major Depressive Disorder

Keywords

Transcranial Magnetic Stimulation,; Antidepressants; iTMS; rTMS

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  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)

  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)

  6 weeks

Study Arms (2)

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.

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.

Drug: Antidepressant

Interventions

Transcranial magnetic stimulation DEVICE

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.

Transcranial magnetic stimulation

Antidepressant DRUG

Selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, SNRIs

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sultan Qaboos University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation; Antidepressive Agents

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 16, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 28, 2024

Record last verified: 2024-10