Unipolar DepressionNCT06363981
Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression
A study testing Active rTMS over the left DLPFC and over the left DMPFC and Active rTMS over the left DLPFC in people with Unipolar Depression and Bipolar Disorder, run by Jakub Antczak at 1 site in Poland.
Trial summary
Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unipolar Depression, Bipolar Disorder
- What is being tested?
- Active rTMS over the left DLPFC and over the left DMPFC and Active rTMS over the left DLPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 20 May 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
- Hamilton Depression Rating Scale between between 20 and 35 points at inclusion
- The score in the Athens Insomnia Scale eight or more
- The score of three or more points in items 4 and 21 of the Beck Depressions Inventory 2
- Complaining about problems with memory and concentration timely related with the onset of depression
Who cannot join
- Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
- Psychotic symptoms at the time of inclusion
- Suicidal ideations and/or attempts within three months prior to inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
The Education of Research and Development Center, Babinski Clinical Hospital
Krakow, 30393
Wojciech Korzeniowski, MD, +48 12 652 42 00, wojciech.korzen@gmail.com
Jakub Antczak, MD, +48 12 25 50, jakub.antczak@uj.edu.pl
About this study
Official title: Multisite Repetitive Transcranial Magnetic Stimulation for Mood, Cognitive Impairment, Anhedonia and Disordered Sleep in Depressive Disorder
Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression.
Read the detailed description
Depression is one of the most common and disabling disorders, affecting approximately three hundred million people worldwide. Depressive mood is the main symptom, but other symptoms like cognitive impairment, anhedonia or sleep disorders contribute significantly to patients suffering, decrease quality of life and may even lead to suicide attempt. While modern pharmacotherapy can significantly improve symptoms in many patients, still one third of patients remains drug-resistant. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method of inducing brain plasticity. Stimulation over the left and right dorsolateral prefrontal cortex (DLPFC) and possibly over several other areas can improve mood. Only few studies investigated the effect of rTMS on negative psychiatric symptoms, such as anhedonia, sleeplessness or cognitive impairment. In these trials, either the DLPFC or the dorsomedial prefrontal cortex (dmPFC) were stimulated and sometimes other areas such as the insular cortex. The aim of this study is to investigate if a stimulation over both sites (multi-site stimulation) has better therapeutic potential for depressed mood, cognitive impairment, anhedonia and sleep disorders than stimulation over DLPFC alone and placebo.
- Conditions
- Unipolar Depression, Bipolar Disorder
- Being tested
- Active rTMS over the left DLPFC and over the left DMPFC, Active rTMS over the left DLPFC, Sham rTMS
- Keywords
- depression, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex, dorsomedial prefrontal cortex, cognitive impairment, anhedonia, sleep disorders
- Medical subject headings
- Depressive Disorder, Bipolar Disorder, Depression, Cognitive Dysfunction, Anhedonia, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMS over the left DLPFC and over the left DMPFCDevice
Active rTMS over the left DLPFC and over the left DMPFC to induce the long term potentiation of stimulated areas.
Active rTMS over the left DLPFCDevice
Active rTMS over the left DLPFC to induce the long term potentiation of stimulated area.
Sham rTMSDevice
Sham rTMS over the left DLPFC or over the left DLPFC and over the left DMPFC for placebo.
| Study group | Role | What they receive |
|---|---|---|
| rTMS over the left DLPFC and over the left DMPFC | Experimental | Active 10 Herz rTMS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus and the right abductor hallucis will be administered over the left DLPFC and over the left DMPFC respectively. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session ca 1500 magnetic pulses over the left DLPFC and ca 1500 over the left DMPFC will be elicited. Receives: Device: Active rTMS over the left DLPFC and over the left DMPFC |
| rTMS over the left DLPFC | Active comparator | Active 10 Herz rTMS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus will be administered over the left DLPFC. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session 3000 magnetic pulses over the left DLPFC will be elicited. Receives: Device: Active rTMS over the left DLPFC |
| Sham rTMS | Sham comparator | Sham 10 Herz rTMS will be administered over the left DLPFC. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session 3000 magnetic pulses over the left DLPFC or ca 1500 magnetic pulses over the left DLPFC and ca 1500 over the left DMPFC will be elicited. (rTMS protocol will be chosen randomly before the first session). Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory 2
Inventory consisting of 21 items measuring cognitive, affective, somatic, and vegetative symptoms of depression. Each item is scored from 0 to 3, with a higher score denoting more severe depression. Items are related to the criteria from the Diagnostic and Statistical Manual of Mental Disorders-IV. The minimum value of the total score is 0 and the maximum is 63 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Measured: Before intervention - four weeks after finishing intervention.
Froward digit span
A measure of verbal short term and working memory. Participant is asked to repeat the random series of numbers, which become longer along with every correctly repeated one. Test is finished after participant failed to respond correctly on three occasions. The number of correctly repeated series determines the final score, which is an integer representing the length of the largest passed sequence. The scores range from 3 to 9 with higher scores denoting better outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Measured: Before intervention - four weeks after finishing intervention.
Language part of Addenbrooke's Cognitive Examination
A test to identify cognitive impairment in dementia. In the language part, participant is asked to complete a set commands such as "place the paper on top of the pencil"; to write grammatically-complete sentences; to repeat several words and proverbs; to name the objects shown in drawings, and answer questions and to read several mispronounced words. The number of correctly completed tasks is scored. The minimum value of the total score is 0 and the maximum (of the language part) is 26 with higher scores meaning better outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Measured: Before intervention - four weeks after finishing intervention.
Secondary outcomes (4)
Dimensional Anhedonia Rating Scale
A 17-item scale that measures desire, motivation, effort and consummatory pleasure across hedonic domains. In each item, participant chooses one of four statements describing his attitude towards a given activity. The minimum value of the total score is 0 and the maximum is 68 with higher scores meaning better outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Measured: Before intervention - four weeks after finishing intervention.
Athens Insomnia Scale
An eight item scale. Each item is rated from 0 to 3 with higher scores representing more severe insomnia. Change from baseline score in the Athens Insomnia Scale to the measurement taken after finishing rTMS. The minimum value of the total score is 0 and the maximum is 24 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Measured: Before intervention - four weeks after finishing intervention.
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI) is a questionnaire to identify sleep disturbances. It consists of a combination of Likert-type and open-ended questions, which are later converted to scaled scores. Scores for each question range from 0 to 3. The minimum value of the total score is 0 and the maximum is 21 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Measured: Before intervention - four weeks after finishing intervention.
Epworth Sleepiness Scale
An eight-item scale. Each item refers to a situation such as driving a car or sitting quietly. The subject is asked to assess the chance of dosing in each situation, ranging from 0 (no chance) to 3 (dosing very likely). The minimum value of the total score is 0 and the maximum is 24 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Measured: Before intervention - four weeks after finishing intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start20 May 2024
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies 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
- Model description
- Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jakub Antczak
- Sponsor type
- University, hospital or other
- Collaborators
- Andrzej Frycz Modrzewski Krakow University
- Responsible party
- Sponsor-investigator, Jakub Antczak, Jagiellonian University
- Investigators
- Wojciech Korzeniowski, MD, Principal investigator, The Education of Research and Development Center, Babinski Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363981
- Sponsor's protocol ID
- JagiellonianU72
- Status last verified
- Oct 2024
- First submitted
- 9 Apr 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scans of scales, inventories and questionnaires will be available upon request sent per e-mail to: wojciech.korzen@gmail.com
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Repetitive Transcranial Magnetic Stimulation for Mood, Cognitive Impairment, Anhedonia and Disordered Sleep in Depressive Disorder
- ClinicalTrials.gov ID
- NCT06363981
- Acronym / sponsor ID
- JagiellonianU72
- Conditions
- Unipolar Depression, Bipolar Disorder
- Keywords
- depression, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex, dorsomedial prefrontal cortex, cognitive impairment, anhedonia, sleep disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jakub AntczakUniversity, hospital or other
- Collaborators
- Andrzej Frycz Modrzewski Krakow University
- Study start
- 20 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Apr 2024 (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.
Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression.
Detailed description
Depression is one of the most common and disabling disorders, affecting approximately three hundred million people worldwide. Depressive mood is the main symptom, but other symptoms like cognitive impairment, anhedonia or sleep disorders contribute significantly to patients suffering, decrease quality of life and may even lead to suicide attempt. While modern pharmacotherapy can significantly improve symptoms in many patients, still one third of patients remains drug-resistant. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method of inducing brain plasticity. Stimulation over the left and right dorsolateral prefrontal cortex (DLPFC) and possibly over several other areas can improve mood. Only few studies investigated the effect of rTMS on negative psychiatric symptoms, such as anhedonia, sleeplessness or cognitive impairment. In these trials, either the DLPFC or the dorsomedial prefrontal cortex (dmPFC) were stimulated and sometimes other areas such as the insular cortex. The aim of this study is to investigate if a stimulation over both sites (multi-site stimulation) has better therapeutic potential for depressed mood, cognitive impairment, anhedonia and sleep disorders than stimulation over DLPFC alone and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design
| Arm | Type | Receives |
|---|---|---|
| rTMS over the left DLPFC and over the left DMPFC | Experimental | Device: Active rTMS over the left DLPFC and over the left DMPFCActive 10 Herz rTMS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus and the right abductor hallucis will be administered over the left DLPFC and over the left DMPFC respectively. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session ca 1500 magnetic pulses over the left DLPFC and ca 1500 over the left DMPFC will be elicited. |
| rTMS over the left DLPFC | Active comparator | Device: Active rTMS over the left DLPFCActive 10 Herz rTMS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus will be administered over the left DLPFC. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session 3000 magnetic pulses over the left DLPFC will be elicited. |
| Sham rTMS | Sham comparator | Device: Sham rTMSSham 10 Herz rTMS will be administered over the left DLPFC. Therapy will include 20 sessions (one session in each of 20 consecutive working days - four weeks in total). In every session 3000 magnetic pulses over the left DLPFC or ca 1500 magnetic pulses over the left DLPFC and ca 1500 over the left DMPFC will be elicited. (rTMS protocol will be chosen randomly before the first session). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
- Hamilton Depression Rating Scale between between 20 and 35 points at inclusion
- The score in the Athens Insomnia Scale eight or more
- The score of three or more points in items 4 and 21 of the Beck Depressions Inventory 2
- Complaining about problems with memory and concentration timely related with the onset of depression
Key exclusion criteria (3 listed)
- Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
- Psychotic symptoms at the time of inclusion
- Suicidal ideations and/or attempts within three months prior to inclusion
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 |
|---|---|---|
| Active rTMS over the left DLPFC and over the left DMPFCActive rTMS over the left DLPFC and over the left DMPFC to induce the long term potentiation of stimulated areas. | Device | rTMS over the left DLPFC and over the left DMPFC |
| Active rTMS over the left DLPFCActive rTMS over the left DLPFC to induce the long term potentiation of stimulated area. | Device | rTMS over the left DLPFC |
| Sham rTMSSham rTMS over the left DLPFC or over the left DLPFC and over the left DMPFC for placebo. | Device | Sham rTMS |
Primary outcome
Beck Depression Inventory 2
Time frame: Before intervention - four weeks after finishing intervention.
Inventory consisting of 21 items measuring cognitive, affective, somatic, and vegetative symptoms of depression. Each item is scored from 0 to 3, with a higher score denoting more severe depression. Items are related to the criteria from the Diagnostic and Statistical Manual of Mental Disorders-IV. The minimum value of the total score is 0 and the maximum is 63 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Froward digit span
Time frame: Before intervention - four weeks after finishing intervention.
A measure of verbal short term and working memory. Participant is asked to repeat the random series of numbers, which become longer along with every correctly repeated one. Test is finished after participant failed to respond correctly on three occasions. The number of correctly repeated series determines the final score, which is an integer representing the length of the largest passed sequence. The scores range from 3 to 9 with higher scores denoting better outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
Language part of Addenbrooke's Cognitive Examination
Time frame: Before intervention - four weeks after finishing intervention.
A test to identify cognitive impairment in dementia. In the language part, participant is asked to complete a set commands such as "place the paper on top of the pencil"; to write grammatically-complete sentences; to repeat several words and proverbs; to name the objects shown in drawings, and answer questions and to read several mispronounced words. The number of correctly completed tasks is scored. The minimum value of the total score is 0 and the maximum (of the language part) is 26 with higher scores meaning better outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.
4 secondary outcomes
Dimensional Anhedonia Rating Scale
Time frame: Before intervention - four weeks after finishing intervention.
Athens Insomnia Scale
Time frame: Before intervention - four weeks after finishing intervention.
Pittsburgh Sleep Quality Index
Time frame: Before intervention - four weeks after finishing intervention.
Epworth Sleepiness Scale
Time frame: Before intervention - four weeks after finishing intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. Scans of scales, inventories and questionnaires will be available upon request sent per e-mail to: wojciech.korzen@gmail.com
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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.
Wojciech Korzeniowski, MD principal investigator
The Education of Research and Development Center, Babinski Clinical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS over the left DLPFC and over the left DMPFC and Active rTMS over the left DLPFC in people with Unipolar Depression and Bipolar Disorder, run by Jakub Antczak at 1 site in Poland.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wojciech Korzeniowski, MD (+48 12 652 45 20, wojciech.korzen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory 2 (time frame: Before intervention - four weeks after finishing intervention.). 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?
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 15 Oct 2024.