Back to resultsREPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION
Primary Purpose
Depression
Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria: In and outpatients aged between 16 and 65 who met DSM-IV criteria for major depressive episode, and who had a score of 25 or higher on the 10-item Montgomery Asberg Depression Rating Scale (MADRS) were included Exclusion Criteria: A history of epilepsy and any other medical disorder that should preclude the administration of rTMS. Only SSRI's, Mirtazapine and Promethazine as psychotropic medication was accepted if the dosage of antidepressive medication had not been changed for 6 weeks, and if the dosage of Promethazine had not been changed for 2 weeks prior to inclusion. Antidepressive medication had to remain stable during the 14 weeks of the study. Furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.
Sites / Locations
- st. Lucas Andreas Ziekenhuis/ HospitalRecruiting
Outcomes
Primary Outcome Measures
To determine the depression (and so the effect of the treatment)we use the 10-item Montgomery Asberg Depression Rating Scale (MADRS)and we measure before tms (T=0), at week 1 (T=1), at week 2 (T=2), at week 4 (T=3), at week 8 (T=4), at week 14 (T=5)
Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale)
Secondary Outcome Measures
-Changes in anxiety
-.Autonomic changes
-.changes in the emotioneal attention, in the emotional memory en in de emotional recognition.
-.Biochemical changes
-.Changes in the EEG
>> measured before tms and after (at T=0 and T=2)
Full Information
NCT ID
NCT00220610
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
St. Lucas Andreas Ziekenhuis Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00220610
Brief Title
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION
Official Title
Right Parietal Inhibition With rTMS in the Treatment of Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
St. Lucas Andreas Ziekenhuis Hospital
4. Oversight
5. Study Description
Brief Summary
Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.During the rTMS session, the coil was centered flat over the right parietal cortex.
We follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure the depression with different rating scales.
We hypothesized that rTMS has a positive effect in the treatment of depression
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
To determine the depression (and so the effect of the treatment)we use the 10-item Montgomery Asberg Depression Rating Scale (MADRS)and we measure before tms (T=0), at week 1 (T=1), at week 2 (T=2), at week 4 (T=3), at week 8 (T=4), at week 14 (T=5)
Title
Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale)
Secondary Outcome Measure Information:
Title
-Changes in anxiety
Title
-.Autonomic changes
Title
-.changes in the emotioneal attention, in the emotional memory en in de emotional recognition.
Title
-.Biochemical changes
Title
-.Changes in the EEG
Title
>> measured before tms and after (at T=0 and T=2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In and outpatients aged between 16 and 65 who met DSM-IV criteria for major depressive episode, and who had a score of 25 or higher on the 10-item Montgomery Asberg Depression Rating Scale (MADRS) were included
Exclusion Criteria:
A history of epilepsy and any other medical disorder that should preclude the administration of rTMS. Only SSRI's, Mirtazapine and Promethazine as psychotropic medication was accepted if the dosage of antidepressive medication had not been changed for 6 weeks, and if the dosage of Promethazine had not been changed for 2 weeks prior to inclusion. Antidepressive medication had to remain stable during the 14 weeks of the study.
Furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judith van der Riet, Drs.
Phone
0031-20-5108562
Email
j.vanderriet@slaz.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G.F Koerselman, prof. dr.
Organizational Affiliation
st Lucas Andreas Ziekenhuis
Official's Role
Study Director
Facility Information:
Facility Name
st. Lucas Andreas Ziekenhuis/ Hospital
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith van der Riet, Drs
Phone
0031-20-5108562
Email
j.vanderriet@slaz.nl
First Name & Middle Initial & Last Name & Degree
G.F Koerselman, Prof.dr.
Phone
0031-20-5108562
Email
f.koerselman@slaz.nl
12. IPD Sharing Statement
Learn more about this trial
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION
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