The Study of Effectiveness of rTMS on Rumination and Anhedonia in Patients With Major Depressive Disorder
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Dec 2016
Typical duration for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2016
CompletedFirst Submitted
Initial submission to the registry
February 6, 2018
CompletedFirst Posted
Study publicly available on registry
March 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedOctober 5, 2022
October 1, 2022
3.8 years
February 6, 2018
October 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
changes in default mode network
EEG
baseline before start of treatment and immediately after the last treatment session.
Anhedonia Symptoms
Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia
baseline before start of treatment and immediately after the last treatment session.
Secondary Outcomes (2)
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
baseline before start of treatment and immediately after the last treatment session.
Depressive symptoms measured by the 21-item Beck Depression Inventory-II
baseline before start of treatment and immediately after the last treatment session.
Study Arms (3)
bilateral rTMS
ACTIVE COMPARATORsequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS
SHAM COMPARATORSham Transcranial Magnetic Stimulation (rTMS)
Unilateral rTMS
ACTIVE COMPARATORUnilateral (High frequency) repetitive Transcranial Magnetic Stimulation (rTMS)
Interventions
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.
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.
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. .
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Tehranlead
- Stanford Universitycollaborator
Study Sites (1)
Atieh Clinical Neuroscience Center (ACNC)
Tehran, 1969713663, Iran
Related 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 Disord. 2022 Nov 15;317:360-372. doi: 10.1016/j.jad.2022.08.098. Epub 2022 Aug 30.
PMID: 36055535RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reza Kazemi, PhD
Atieh Clinical Neuroscience center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
February 6, 2018
First Posted
March 16, 2018
Study Start
December 21, 2016
Primary Completion
September 30, 2020
Study Completion
October 30, 2020
Last Updated
October 5, 2022
Record last verified: 2022-10