Bipolar Depression, Major Depressive Disorder
Conditions
Keywords
MDD, rTMS, Rumination, Anhedonia
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.
Interventions
DEVICEBilateral 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.
DEVICESham 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.
DEVICEUnilateral 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. .
Sponsors
Stanford University
University of Tehran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rumination Symptoms | 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). |
| changes in default mode network | baseline before start of treatment and immediately after the last treatment session. | EEG |
| Anhedonia Symptoms | baseline before start of treatment and immediately after the last treatment session. | Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale | 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 |
| Depressive symptoms measured by the 21-item Beck Depression Inventory-II | 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 |
Countries
Iran
Outcome results
None listed