Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-07-31

Brief Summary

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The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.

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Detailed Description

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Conditions

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Depressive Disorder, Treatment-Resistant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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iTBS-1800

The active group will receive 1800 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.

Group Type EXPERIMENTAL

iTBS-1800

Intervention Type DEVICE

Participants in the 1800-pulse intermittent TBS (iTBS-1800) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \& More stimulator.

iTBS-1200

The active group will receive 1200 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.

Group Type EXPERIMENTAL

iTBS-1200

Intervention Type DEVICE

Participants in the 1200-pulse intermittent TBS (iTBS-1200) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \& More stimulator.

Interventions

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iTBS-1800

Participants in the 1800-pulse intermittent TBS (iTBS-1800) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \& More stimulator.

Intervention Type DEVICE

iTBS-1200

Participants in the 1200-pulse intermittent TBS (iTBS-1200) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \& More stimulator.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The diagnosis of major depressive disorder according to DSM-5
2. Total HAM-D17 score of greater than or equal to 18 and Item 3 score less than 4 at screening visit. CGI-S score less than 4.
3. Before treatment, patient have to stop antidepressant for at least 1 weeks.
4. Capable and willing to provide informed consent.

Exclusion Criteria

1. Have a concomitant major, unstable medical or neurologic illness :

* Psychiatric disorder: Schizoprenia, Bipolar disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, substance use disorder.
* Severe brian disease: Brain tumor, encephalitis, brian injury.
2. Intracranial implant and other ferromagnetic materials close to the head.
3. History of Seizures.
4. Cardiac pacemaker.
5. Pregnancy.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No