An interventional study of Bilateral rTMS and Sham rTMS in Major Depressive Disorder and Bipolar Depression, sponsored by University of Tehran. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by University of Tehran · Not applicable, Interventional, and Treatment
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.
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.
3,046 studies on the registry are indexed under Depressive Disorder, Major; 592 are open to participants now.
This study's enrollment of 61 is below the median of 80 across 2,532 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →University of Tehran is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
sequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS)
Device: Bilateral rTMS
Sham Transcranial Magnetic Stimulation (rTMS)
Device: Sham rTMS
Unilateral (High frequency) repetitive Transcranial Magnetic Stimulation (rTMS)
Device: Unilateral rTMS (High frequency)
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. .
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).
Time frame: baseline before start of treatment and immediately after the last treatment session.
changes in default mode network
EEG
Time frame: baseline before start of treatment and immediately after the last treatment session.
Anhedonia Symptoms
Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia
Time frame: baseline before start of treatment and immediately after the last treatment session.
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
Time frame: baseline before start of treatment and immediately after the last treatment session.
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
Time frame: baseline before start of treatment and immediately after the last treatment session.
Ran from Dec 2016 to primary completion in Sep 2020, 45 months.
Of 648 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's 45 months is above that.
Counting every sponsor, half of 688 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University of Tehran