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

Primary Purpose

Major Depressive Disorder, Bipolar Depression

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Bilateral rTMS
Sham rTMS
Unilateral rTMS (High frequency)
Sponsored by
University of Tehran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, rTMS, Rumination, Anhedonia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Atieh Clinical Neuroscience Center (ACNC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

bilateral rTMS

Sham rTMS

Unilateral rTMS

Arm Description

sequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS)

Sham Transcranial Magnetic Stimulation (rTMS)

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

Outcomes

Primary Outcome Measures

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).
changes in default mode network
EEG
Anhedonia Symptoms
Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia

Secondary Outcome Measures

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
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

Full Information

First Posted
February 6, 2018
Last Updated
October 4, 2022
Sponsor
University of Tehran
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03468686
Brief Title
The Study of Effectiveness of rTMS on Rumination and Anhedonia in Patients With Major Depressive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 21, 2016 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tehran
Collaborators
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Bipolar Depression
Keywords
MDD, rTMS, Rumination, Anhedonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bilateral rTMS
Arm Type
Active Comparator
Arm Description
sequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS)
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham Transcranial Magnetic Stimulation (rTMS)
Arm Title
Unilateral rTMS
Arm Type
Active Comparator
Arm Description
Unilateral (High frequency) repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Type
Device
Intervention Name(s)
Bilateral rTMS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Unilateral rTMS (High frequency)
Intervention Description
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. .
Primary Outcome Measure Information:
Title
Rumination Symptoms
Description
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).
Time Frame
baseline before start of treatment and immediately after the last treatment session.
Title
changes in default mode network
Description
EEG
Time Frame
baseline before start of treatment and immediately after the last treatment session.
Title
Anhedonia Symptoms
Description
Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia
Time Frame
baseline before start of treatment and immediately after the last treatment session.
Secondary Outcome Measure Information:
Title
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
Description
Hamilton Depression Rating Scale (HDRS),(HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22
Time Frame
baseline before start of treatment and immediately after the last treatment session.
Title
Depressive symptoms measured by the 21-item Beck Depression Inventory-II
Description
Beck Depression Inventory-II (BDI-II), (BDI-II) Range: 0-63 Normal: 0-13 Mild: 14- 9 Moderate 20- 28 Severe: 29-63
Time Frame
baseline before start of treatment and immediately after the last treatment session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Kazemi, PhD
Organizational Affiliation
Atieh Clinical Neuroscience center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atieh Clinical Neuroscience Center (ACNC)
City
Tehran
ZIP/Postal Code
1969713663
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
36055535
Citation
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 Disord. 2022 Nov 15;317:360-372. doi: 10.1016/j.jad.2022.08.098. Epub 2022 Aug 30.
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The Study of Effectiveness of rTMS on Rumination and Anhedonia in Patients With Major Depressive Disorder

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