Major Depressive DisorderNCT03468686
The Study of Effectiveness of rTMS on Rumination and Anhedonia in Patients With Major Depressive Disorder
A study testing Bilateral rTMS and Unilateral rTMS (High frequency) in people with Major Depressive Disorder and Bipolar Depression, run by University of Tehran at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Depression
- What is being tested?
- Bilateral rTMS and Unilateral rTMS (High frequency)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteIran
- Study dates
- 21 Dec 2016to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Bipolar Depression
- Being tested
- Bilateral rTMS, Sham rTMS, Unilateral rTMS (High frequency)
- Keywords
- MDD, rTMS, Rumination, Anhedonia
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Rumination Syndrome, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral rTMSDevice
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.
Sham rTMSDevice
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.
Unilateral rTMS (High frequency)Device
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. .
| Study group | Role | What they receive |
|---|---|---|
| bilateral rTMS | Active comparator | sequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS) Receives: Device: Bilateral rTMS |
| Sham rTMS | Sham comparator | Sham Transcranial Magnetic Stimulation (rTMS) Receives: Device: Sham rTMS |
| Unilateral rTMS | Active comparator | Unilateral (High frequency) repetitive Transcranial Magnetic Stimulation (rTMS) Receives: Device: Unilateral rTMS (High frequency) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline before start of treatment and immediately after the last treatment session.
changes in default mode network
EEG
Measured: baseline before start of treatment and immediately after the last treatment session.
Anhedonia Symptoms
Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia
Measured: 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
Hamilton Depression Rating Scale (HDRS),(HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22
Measured: 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
Measured: baseline before start of treatment and immediately after the last treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start21 Dec 2016
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, reza kazemi, University of Tehran
- Investigators
- Reza Kazemi, PhD, Principal investigator, Atieh Clinical Neuroscience center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468686
- Sponsor's protocol ID
- 4748
- Status last verified
- Oct 2022
- First submitted
- 6 Feb 2018
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36055535
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03468686
- Acronym / sponsor ID
- 4748
- Conditions
- Major Depressive Disorder, Bipolar Depression
- Keywords
- MDD, rTMS, Rumination, Anhedonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bilateral rTMS | Active comparator | Device: Bilateral rTMSsequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS) |
| Sham rTMS | Sham comparator | Device: Sham rTMSSham Transcranial Magnetic Stimulation (rTMS) |
| Unilateral rTMS | Active comparator | Device: Unilateral rTMS (High frequency)Unilateral (High frequency) repetitive Transcranial Magnetic Stimulation (rTMS) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- The history of rTMS treatment for any reason
- Cardiac pacemaker
- The risk of seizure with any reasons
- Pregnancy
- High risk of suicide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral rTMSThe 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. | Device | bilateral rTMS |
| Sham rTMSThe 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. | Device | Sham rTMS |
| Unilateral 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. . | Device | Unilateral rTMS |
Primary outcome
Rumination Symptoms
Time frame: 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
Time frame: baseline before start of treatment and immediately after the last treatment session.
EEG
Anhedonia Symptoms
Time frame: baseline before start of treatment and immediately after the last treatment session.
Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia
2 secondary outcomes
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
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
Time frame: baseline before start of treatment and immediately after the last treatment session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Results publication: PubMed 36055535Kazemi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Kazemi, PhD principal investigator
Atieh Clinical Neuroscience center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral rTMS and Unilateral rTMS (High frequency) in people with Major Depressive Disorder and Bipolar Depression, run by University of Tehran at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rumination Symptoms (time frame: baseline before start of treatment and immediately after the last treatment session.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.