Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation

Chang Gung Memorial Hospital70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

iTBS-1800DEVICE

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-1200DEVICE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

ChangGungMH

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

Change in 17-item Hamilton Depression Rating Scale

17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression)