Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation (iTBS)

Chang Gung Medical Foundation

Status: Unknown

Conditions: Depressive Disorder, Treatment-Resistant

Treatments: Device: iTBS-1800; Device: iTBS-1200

Study type: Interventional

Funder types: Other

Identifiers

NCT05390593

CMRPG8L0871

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

iTBS-1800

Experimental group

Description:

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

Treatment:

Device: iTBS-1800

iTBS-1200

Experimental group

Description:

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

Treatment:

Device: iTBS-1200