Transcranial Magnetic Stimulation vs Theta Burst Stimulation in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Blinded, Randomized Trial Comparing the Effects of Transcranial Magnetic Stimulation and Theta Burst Stimulation in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04497350
• Other study ID #: 20193262
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: December 2024

Study information

• Verified date: September 2022
• Source: Neurological Associates of West Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the differences in efficacy between transcranial magnetic stimulation (TMS) and intermittent theta burst stimulation (iTBS) treatment in subjects suffering from major depressive disorder.

Description:

Up to 30 patients of any gender aged from 18 to 70 years old will be recruited for inclusion once candidacy has been established by screening criteria.

Once recruited, patients will be randomly assigned to the TMS treatment group or the iTBS treatment group. Patients will be blinded to their group assignment, but will be informed of their assignment upon the final outcome measure collection timepoint (e.g., 1 month post-treatment). Patients who failed to respond by 1-month post iTBS or TMS treatment will be allowed to cross-over into the other treatment group and will be re-enrolled into the study.

For patients assigned to the TMS treatment group, the treatment protocol will consist of 20 sessions of TMS treatment. Each TMS session will deliver 5,000 pulses (120-140% MT, continuous temperature of 24C) over an 61 minute, 51 second time period. Patients will have one TMS session per day, five days a week, until their treatment is completed (approximately four weeks). Upon completion, the patient's depressive symptomatology and severity will be assessed using the same outcome measures used at baseline.

For patients assigned to the iTBS treatment group, the treatment protocol will consist of 20 sessions of iTBS treatment. Each iTBS session will deliver 1,800 pulses (120-140% MT, continuous temperature of 24C) over an 9-minute-40-second period. Patients will have up to four iTBS sessions per day, five days a week, until their treatment is completed (approximately 1 week). Upon completion, the patient's depressive symptomatology and severity will be assessed using the same outcome measures used at baseline.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Major Depressive Disorder

• Score greater than 13 on the Beck Depression Inventory

• Failure to remit with 3 antidepressants

• At least 18 years of age

• Must be willing to comply with the study protocol

• English Proficiency

Exclusion Criteria:

• Hepatic impairment

• Significant cytopenia

• Cardiovascular, cerebrovascular, and peripheral vascular arterial thrombosis

• Advanced terminal illness

• Any active cancer or chemotherapy

• Bone marrow disease

• Neurodegenerative diseases

• Myeloproliferative disorders

• Sickle cell disease

• Subjects with scalp rash or open wounds on the scalp

• Women who are pregnant, may become pregnant, or are breastfeeding

• Subjects unable to give informed consent or in vulnerable categories, such as prisoners

• Subjects who would not be able to lay down without excessive movement

• Recent surgery or dental work within 3 months of the scheduled procedure

• Not English Proficient

• Advanced stages of any terminal illness or any active cancer that requires chemotherapy

• History of epilepsy or seizure, or history of such in first degree relative

• An increased risk of seizure for any reason

• Stents in the neck or brain

• Aneurysm clips or coils

• Metal devices/objects in or near the head

• Metallic implants near the ears and eyes

• Facial tattoos with metallic or magnetic-sensitive ink

• Comorbid psychiatric conditions

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Transcranial Magnetic Stimulation
5,000 pulses (120-140% MT, continuous temperature of 24C) will be delivered per session (see Appendix A for timing parameters). Patients will have one TMS session per day, five days a week, until their treatment is completed (approximately four weeks).
• Theta Burst Stimulation
One session of iTBS will deliver 1,800 pulses (120-140% MT, continuous temperature of 22ºC) over an 9-minute-40-second period. The minimum break period between iTBS sessions is 25 minutes.

Locations

Country	Name	City	State
United States	Neurological Associates of West Los Angeles	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurological Associates of West Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory (BDI-II)	The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.	1 month
Primary	Patient Depression Questionnaire (PDQ-9)	The PDQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.	1 month
Primary	Hamilton Depression Rating Scale (HAM-D)	The HAM-D is a 17-item, interview style questionnaire. A trained staff member administers this form to a patient and scores the patients' responses on a scale of "0" (symptom absent) to "4" (most severe option per symptom). A higher total score indicates a more severe level of depression. The maximum possible score is 50 points. A change in score of at least 30% is considered clinically meaningful.	1 month
Primary	Global Rating of Change (GRC)	The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.	1 month
Secondary	Beck Depression Inventory (BDI-II)	The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.	2 months
Secondary	Patient Depression Questionnaire (PDQ-9)	The PDQ-9 is a 9-item, self-report questionnaire to evaluate for depressive symptoms. Each question asks the patient if they have experienced a particular depressive symptom over the past two weeks. Answers may range from "0" (not at all), "1" (several days/week), "2" (more than half of the days), and "3" (nearly every day). Maximum total score is 27 points. A higher score indicates more severe depressive symptoms. A reduction in total score by at least 30% is considered clinically meaningful.	2 months
Secondary	Hamilton Depression Rating Scale (HAM-D)	The HAM-D is a 17-item, interview style questionnaire. A trained staff member administers this form to a patient and scores the patients' responses on a scale of "0" (symptom absent) to "4" (most severe option per symptom). A higher total score indicates a more severe level of depression. The maximum possible score is 50 points. A change in score of at least 30% is considered clinically meaningful.	2 months
Secondary	Global Rating of Change (GRC)	The GRC consists of a single likert-scale ranging from "-5" (very much worse) to "0" (neutral/no change) to "5" (very much better). The GRC is obtained in an interview format to assess a patient's perceived change in status following a treatment. A score that is at least 2 or greater is considered to indicate clinically significant change.	2 months