Clinical trial NCT03468686: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Bipolar Depression
Keywords: MDD
rTMS
Rumination
Anhedonia
Lead sponsor: University of Tehran
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2018-03-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rumination Symptoms
timeFrame: baseline before start of treatment and immediately after the last treatment session.
measure: changes in default mode network
timeFrame: baseline before start of treatment and immediately after the last treatment session.
measure: Anhedonia Symptoms
timeFrame: baseline before start of treatment and immediately after the last treatment session.
Secondary outcomes:
measure: Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
timeFrame: baseline before start of treatment and immediately after the last treatment session.
measure: Depressive symptoms measured by the 21-item Beck Depression Inventory-II
timeFrame: baseline before start of treatment and immediately after the last treatment session.
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Atieh Clinical Neuroscience Center (ACNC)
Study officials:
affiliation: Atieh Clinical Neuroscience center
name: Reza Kazemi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.