The Study of Effectiveness of rTMS on Rumination and Anhedonia in Patients With Major Depressive Disorder

University of Tehran

Status: Completed

Conditions: Major Depressive Disorder; Bipolar Depression

Treatments: Device: Sham rTMS; Device: Unilateral rTMS (High frequency); Device: Bilateral rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03468686

4748

Details and patient eligibility

About

Rumination is significantly frequent in major depressive disorder. However, not a lot of studies have investigated the effects of repetitive transcranial magnetic stimulation on rumination and its electrophysiological correlates. This study recruited 61 participants who were randomly assigned to sham, bilateral, or unilateral stimulation groups to investigate the potential differences between these stimulation protocols and changes in the behavioral and electrophysiological outcomes after treatment.

Full description

This study aims to compare the effect of unilateral and bilateral rTMS on the reduction of rumination and anhedonia and their associated neural networks. In a randomized double-blind trial, 65 patients with depressive disorder in Atieh Clinical Neuroscience Center are assigned to three groups. The first group receives bilateral rTMS for 20 sessions on right and left DLPFC; the second group receives unilateral rTMS for 20 sessions on LDLPFC; third group receives sham rTMS for 10 sessions. In this group, the stimulation parameters are similar to that in the actual rTMS group, except that the coil angel is 90° and perpendicular to the head. Rumination and anhedonia symptoms will be measured by the Ruminative Responses Scale (RRS) and Snaith-Hamilton Pleasure Scale (SHAPS) in the baseline and after the 20th session. In order to investigate the neural networks associated with rumination and anhedonia, EEG of patients will be recorded at the first session and at the end of the treatment.

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients male and female with the range of 18-65 years of age
• The diagnosis of Major depressive disorder according to DSM-V
• Having BDI>18
• Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks
• Completion of consent form
• Being under supervision of a psychiatrist

Exclusion criteria

• The history of rTMS treatment for any reason
• Cardiac pacemaker
• The risk of seizure with any reasons
• Pregnancy
• High risk of suicide
• Intracranial implant and other ferromagnetic materials close to the head

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 3 patient groups

bilateral rTMS

Active Comparator group

Description:

sequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS)

Treatment:

Device: Bilateral rTMS

Sham rTMS

Sham Comparator group

Description:

Sham Transcranial Magnetic Stimulation (rTMS)

Treatment:

Device: Sham rTMS

Unilateral rTMS

Active Comparator group

Description:

Unilateral (High frequency) repetitive Transcranial Magnetic Stimulation (rTMS)

Treatment:

Device: Unilateral rTMS (High frequency)