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

October 4, 2022 updated by: reza kazemi, University of Tehran

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: bilateral rTMS
sequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS)
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_COMPARATOR: Sham rTMS
Sham Transcranial Magnetic Stimulation (rTMS)
Device: 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.
ACTIVE_COMPARATOR: Unilateral rTMS
Unilateral (High frequency) repetitive Transcranial Magnetic Stimulation (rTMS)
Device: 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. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rumination Symptoms
Time Frame: baseline before start of treatment and immediately after the last treatment session.
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.
changes in default mode network
Time Frame: baseline before start of treatment and immediately after the last treatment session.
EEG
baseline before start of treatment and immediately after the last treatment session.
Anhedonia Symptoms
Time Frame: baseline before start of treatment and immediately after the last treatment session.
Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia
baseline before start of treatment and immediately after the last treatment session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
Time Frame: baseline before start of treatment and immediately after the last treatment session.
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.
Depressive symptoms measured by the 21-item Beck Depression Inventory-II
Time Frame: baseline before start of treatment and immediately after the last treatment session.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tehran

Collaborators

Stanford University

Investigators

  • Principal Investigator: Reza Kazemi, PhD, Atieh Clinical Neuroscience center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2016

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

October 30, 2020

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (ACTUAL)

March 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4748

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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