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recruiting of patients difficult combined by lack of money
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The aim of the present study is to investigate in which degree low frequency right prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate remission .
To investigate the correlation between blood concentration of specific inflammation makers and change in depressive symptoms during treatment
ECT is a well-established and effective method for the treatment of severe depression. During the last decades, rTMS has appeared as a potential new non-invasive antidepressant method, which may be a potential alternative to ECT due to fewer side effects.
Both methods expose the brain to an electric current. But while ECT is associated with global cerebral stimulation elicited by an epileptic seizure, rTMS implies non-convulsive focal stimulation through a time varying magnetic field. Thus, the antidepressant effect of rTMS does not depend on seizure activity and consequently requires no anesthesia. In addition, rTMS seems not to be associated with cognitive disturbances.
Previous research indicates that the antidepressant effect of rTMS is associated with specific stimulation of the dorsolateral prefrontal cortex. The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex (1-4). Few have used right prefrontal low frequency rTMS, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation (5-10). Both models have been used with varying results. Meta-analysis of the antidepressant effect of rTMS (11,x) have found a modest, statistically significant antidepressant effect but generally definite conclusions on the antidepressant effect of rTMS has been difficult to draw, probably because of small and selected study populations, varying ways of stimulation and other confounding factors in the clinical setting.
The important clinical question of whether rTMS may substitute ECT in the treatment of depression has almost exclusively been elucidated in studies using high frequency stimulation of the left frontal cortex. Some of these suggest that the effectiveness of rTMS is equal to that of ECT in non-delusional patients (12-19). However, a recent investigation has compared the antidepressant efficacy and side effects of right prefrontal low frequency rTMS with ECT. In this study the mean Hamilton total 17-item (HAM-D score) scores were reduced significantly over time in both groups (ECT: p<0.001, rTMS: p<0.001); but ECT was more effective than rTMS on a short term after 3 weeks of treatment. The outcome did not point to right frontal low frequency rTMS as a first line substitute for ECT, but it might have place in the treatment of depression as add on to other types of treatment.
ECT is normally administered 3 times a week for 3-4 weeks. Daily treatment sessions might accelerate remission, but is impossible because of cognitive side effects. However, rTMS seems not to be associated with reduction in cognitive performance and might potentiate the antidepressant efficacy of ECT. Therefore the investigators have found it clinical interesting to investigate in which degree low frequency right prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate remission .
In addition we want to investigate te correlation between change in depressive symptoms and
-blood concentration of specific inflammation CNS- makers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low frequency rTMS | Experimental | Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week |
|
| Sham-rTMS | Sham Comparator | Sham right prefrontal rTMS 2 times a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low frequency (1 hz) rTMS, as add-on to ECT | Device | Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission | The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcomeRemission is defined by a Hamilton 17-item total score < 8. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response | The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcome. Response is defined by a reduction in the Hamilton 17 item score of >= 50% | 7 weeks |
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Inclusion Criteria:
Patients admitted to the Psychiatric Hospital of Aarhus
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Poul Erik Buchholtz, MD | Poul Erik Buchholtz, MD Telephone: 004578472109 Email: poulhans@rm.dk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Risskov | Aarhus | Risskov | 8240 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Right Prefrontal Low Frequency (1 hz) Repetitive Transcranial Magnetic Stimulation (rTMS) | Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT. |
| FG001 | Sham- Right Prefrontal Low Frequency (1 hz) Repetitive Transcranial Magnetic Stimulation (rTMS) | Sham right prefrontal rTMS 2 times a week Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) | Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Remission | The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcomeRemission is defined by a Hamilton 17-item total score < 8. | Posted | Count of Participants | Participants | 7 weeks |
|
7 weeks
All-Cause Mortality monitored/assessed in all participants who completed the study. Serious and Other adverse events were monitored/assessed in 26 participants (74% of the population).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Frequency rTMS | Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week Low frequency (1 hz) rTMS, as add-on to ECT: Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| severe confusion | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild discomfort during treatment | Skin and subcutaneous tissue disorders | Systematic Assessment |
The study is under-powered
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Poul Erik Buchholtz | Department of Affective Disorder, Aarhus University Hospital, Denmark | 21474299 | Buchholtz.Hansen@ps.rm.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2015 | Feb 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Sham-rTMS | Device | Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT. |
|
| BG001 |
| Sham-rTMS |
Sham right prefrontal rTMS 2 times a week Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hamilton depression scale score | The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. Full range = 0-52. The Hamilton 6-item subscale coveres 6 core symptoms of the 17 items. Full range = 0-22 The major depression inventory scale is a self-reported modd questionnaire which is able to generate an estimate of symptom severety. The scale coveres 10 items. Full range =0-50 Increasing scores correlate to increasing severity of depression on all of the above mentioned scores. | Mean | Full Range | units on a scale |
|
| Number of patients with Severe depression | Count of Participants | Participants |
|
| number of patients with bipolar depressive | Count of Participants | Participants |
|
| number of patients with melancholic depression | Count of Participants | Participants |
|
| number of patients with psychotic depression | Count of Participants | Participants |
|
| Antidepressant drug treatment | Count of Participants | Participants |
|
Sham right prefrontal rTMS 2 times a week
Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.
|
|
|
| Secondary | Response | The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcome. Response is defined by a reduction in the Hamilton 17 item score of >= 50% | Posted | Count of Participants | Participants | 7 weeks |
|
|
|
| 0 |
| 17 |
| 1 |
| 12 |
| 4 |
| 12 |
| EG001 | Sham-rTMS | Sham right prefrontal rTMS 2 times a week Sham-rTMS: Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT. | 0 | 17 | 0 | 14 | 3 | 14 |
| mild headache | Nervous system disorders | Systematic Assessment |
|
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