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

Major Depressive Disorder Clinical Trial

Official title:

The Study of Effectiveness of Unilateral and Bilateral Repetitive Transcranial Magnetic Stimulation (rTMS) on Rumination and Anhedonia in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468686
• Other study ID #: 4748
• Status: Completed
• Phase: N/A
• Start date: December 21, 2016
• Est. completion date: October 30, 2020

Study information

• Verified date: October 2022
• Source: University of Tehran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anhedonia
• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Bilateral rTMS
The coil will locate on F3 and F4 in accordance with the 10-20 international system. bilateral rTMS include stimulate the right DLPFC at 1 Hz for a 10 seconds train of stimulation, and a total of 150 pulse trains. Immediately after that, the stimulation was carried out on the left DLPFC at 10 Hz, 5 seconds of stimulation, with 10 second inter-train interval and 75 pulse trains.
• Sham rTMS
The same parameters will use in the sham rTMS. However, the coil adjust at an angle of 90º vertically on the skull in a way that one wing place on the head.
• Unilateral rTMS (High frequency)
The coil will locate on F3 in accordance with the 10-20 international system. Unilateral rTMS include stimulate the Left DLPFC at 10Hz for a 5seconds train of stimulation, 10 seconds inter-train interval, and a total of 75 pulse trains. .

Locations

Country	Name	City	State
Iran, Islamic Republic of	Atieh Clinical Neuroscience Center (ACNC)	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
University of Tehran	Stanford University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

Kazemi R, Rostami R, Nasiri Z, Hadipour AL, Kiaee N, Coetzee JP, Philips A, Brown R, Seenivasan S, Adamson MM. Electrophysiological and behavioral effects of unilateral and bilateral rTMS; A randomized clinical trial on rumination and depression. J Affect — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rumination Symptoms	The Ruminative Responses Scale (RRS) is a measure of depressive rumination which has two subscales: Both subscales are composed of five items. Brooding and Reflection. Higher score indicate a higher level of ruminative responses (range: 22-88).	baseline before start of treatment and immediately after the last treatment session.
Primary	changes in default mode network	EEG	baseline before start of treatment and immediately after the last treatment session.
Primary	Anhedonia Symptoms	Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia	baseline before start of treatment and immediately after the last treatment session.
Secondary	Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale	Hamilton Depression Rating Scale (HDRS),(HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22	baseline before start of treatment and immediately after the last treatment session.
Secondary	Depressive symptoms measured by the 21-item Beck Depression Inventory-II	Beck Depression Inventory-II (BDI-II), (BDI-II) Range: 0-63 Normal: 0-13 Mild: 14- 9 Moderate 20- 28 Severe: 29-63	baseline before start of treatment and immediately after the last treatment session.