Major Depressive DisorderNCT03718013
Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS)
A study testing accelerated deep TMS and standard deep TMS in people with Major Depressive Disorder, run by Sveti Ivan Psychiatric Hospital at 1 site in Croatia.
Trial summary
The purpose of this study is to examine the efficacy and safety of accelerated transcranial magnetic stimulation with H1-coil (deep TMS) for treatment of patients diagnosed with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- accelerated deep TMS and standard deep TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Dec 2018to 1 Nov 2019
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed major depressive disorder (ICD10: F32.1, F32.2, F33.1, F33.2)
- current depressive episode lasts for at least 4 weeks
- HAM-D17 score ≥15
- CGI-Score ≥4
- inadequate response to antidepressant therapy
Who cannot join
- diagnosed psychotic disorder
- diagnosed depressive disorder with psychotic features
- diagnosed bipolar affective disorder
- diagnosed posttraumatic stress disorder
- diagnosed obsessive-compulsive disorder
- anxiety disorder or personality disorder as primary diagnoses
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- alcohol or drug addiction
- neurological disorders and brain implants
- pregnancy
- former TMS treatment within 6 months
- unable to complete the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS); Randomized Controlled Equivalence Trial
The purpose of this study is to examine the efficacy and safety of accelerated transcranial magnetic stimulation with H1-coil (deep TMS) for treatment of patients diagnosed with major depressive disorder (MDD). Subjects will be randomized into two groups: experimental (treated with accelerated deep TMS: twice a day (6-8 hours between two applications), during 2 weeks) and control group (standard deep TMS treatment: once a day, during 4 weeks). Participants and designated clinicians will complete a battery of instruments that measure relevant symptoms (HAM-D17 and BDI-II scales), global functioning (CGI and PHQ-9 scales), quality of life (EQ-5D-5L questionnaire), and cognitive functions (MoCA test). Measurements will be done in 4 time points: after the inclusion, after the first week of treatment, after the second week (the end of treatment for experimental group), after the fourth week (the end of treatment for control group), and after 1 month (follow-up for both groups). Interim data analysis is planned at the time when at least 30 participants are involved in both groups. Patients whose baseline score on HAM-D17 is equal or greater than 24 (very severe depression) will be included in another study; they will be treated with accelerated deep TMS twice a day during 4 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- accelerated deep TMS, standard deep TMS
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accelerated deep TMSDevice
subjects treated with deep TMS twice a day (6-8 hours between two applications), during 2 weeks
standard deep TMSDevice
standard deep TMS treatment: once a day, during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| accelerated dTMS | Experimental | Not described Receives: Device: accelerated deep TMS |
| standard dTMS | Active comparator | Not described Receives: Device: standard deep TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage improvement in the Hamilton Rating Scale for Depression (HAM-D) scores
The Hamilton Rating Scale for Depression (HAM-D) is a clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. The items are scored either on a 3-point or 5-point scale, and all the values are summed to obtain a total scale score. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression (the maximum score being 52).
Measured: 8 weeks
Secondary outcomes (5)
Treatment response
≥50% decrease in scores on the Hamilton Rating Scale for Depression (HAM-D)
Measured: 8 weeks
The proportion of patients who experienced complete remission of the disease
Measured: 8 weeks
Percentage improvement in BDI-II scores
The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Each answer is scored on a scale value of 0 to 3. All the values are summed to obtain a total scale score. Higher total scores indicate more severe depressive symptoms. Scores of 0-13 are considered as minimal depression,14-19 suggest mild depression, 20-28 moderate depression, and 29-63 severe depression.
Measured: 8 weeks
Change in perceived quality of life (EQ-5D-5L scale)
The EQ-5D-5L is a standardised self-report measure of health status developed by the EuroQol Group. It consists of the descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises the 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), and each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent´s decision results in a 1-digit number expressing the level selected for that dimension. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (number 100) and 'the worst health you can imagine' (number 0). The respondents are asked to mark an X on the scale to indicate how their health is today and then to write the number they marked on the scale in the box below.
Measured: 8 weeks
Change in cognitive functions (MoCA test)
The Montreal Cognitive Assessment (MoCA) is a one-page 30-point screening assessment for detecting cognitive impairment. It assesses several cognitive domains: the short-term memory recall task (5 points), visuospatial abilities (4 points), multiple aspects of executive functions (4 points), attention, concentration, and working memory (6 points), language (5 points), and orientation to time and place (6 points). A score of 26 or over is considered to be normal.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Dec 2018
- Primary completion31 Jul 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sveti Ivan Psychiatric Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718013
- Sponsor's protocol ID
- acceleratedDTMS
- Status last verified
- Feb 2020
- First submitted
- 16 Oct 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS); Randomized Controlled Equivalence Trial
- ClinicalTrials.gov ID
- NCT03718013
- Acronym / sponsor ID
- acceleratedDTMS
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Sveti Ivan Psychiatric HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 24 Oct 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.
The purpose of this study is to examine the efficacy and safety of accelerated transcranial magnetic stimulation with H1-coil (deep TMS) for treatment of patients diagnosed with major depressive disorder (MDD). Subjects will be randomized into two groups: experimental (treated with accelerated deep TMS: twice a day (6-8 hours between two applications), during 2 weeks) and control group (standard deep TMS treatment: once a day, during 4 weeks). Participants and designated clinicians will complete a battery of instruments that measure relevant symptoms (HAM-D17 and BDI-II scales), global functioning (CGI and PHQ-9 scales), quality of life (EQ-5D-5L questionnaire), and cognitive functions (MoCA test). Measurements will be done in 4 time points: after the inclusion, after the first week of treatment, after the second week (the end of treatment for experimental group), after the fourth week (the end of treatment for control group), and after 1 month (follow-up for both groups). Interim data analysis is planned at the time when at least 30 participants are involved in both groups. Patients whose baseline score on HAM-D17 is equal or greater than 24 (very severe depression) will be included in another study; they will be treated with accelerated deep TMS twice a day during 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| accelerated dTMS | Experimental | Device: accelerated deep TMS |
| standard dTMS | Active comparator | Device: standard deep TMS |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosed major depressive disorder (ICD10: F32.1, F32.2, F33.1, F33.2)
- current depressive episode lasts for at least 4 weeks
- HAM-D17 score ≥15
- CGI-Score ≥4
- inadequate response to antidepressant therapy
Key exclusion criteria (11 listed)
- diagnosed psychotic disorder
- diagnosed depressive disorder with psychotic features
- diagnosed bipolar affective disorder
- diagnosed posttraumatic stress disorder
- diagnosed obsessive-compulsive disorder
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 |
|---|---|---|
| accelerated deep TMSsubjects treated with deep TMS twice a day (6-8 hours between two applications), during 2 weeks | Device | accelerated dTMS |
| standard deep TMSstandard deep TMS treatment: once a day, during 4 weeks | Device | standard dTMS |
Primary outcome
Percentage improvement in the Hamilton Rating Scale for Depression (HAM-D) scores
Time frame: 8 weeks
The Hamilton Rating Scale for Depression (HAM-D) is a clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. The items are scored either on a 3-point or 5-point scale, and all the values are summed to obtain a total scale score. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression (the maximum score being 52).
5 secondary outcomes
Treatment response
Time frame: 8 weeks
The proportion of patients who experienced complete remission of the disease
Time frame: 8 weeks
Percentage improvement in BDI-II scores
Time frame: 8 weeks
Change in perceived quality of life (EQ-5D-5L scale)
Time frame: 8 weeks
Change in cognitive functions (MoCA test)
Time frame: 8 weeks
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 12 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accelerated deep TMS and standard deep TMS in people with Major Depressive Disorder, run by Sveti Ivan Psychiatric Hospital at 1 site in Croatia.
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 11 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 12 Feb 2020. 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 Croatia. 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. 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?
Percentage improvement in the Hamilton Rating Scale for Depression (HAM-D) scores (time frame: 8 weeks). 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 12 Feb 2020.