REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION

Depression Clinical Trial

Official title:

Right Parietal Inhibition With rTMS in the Treatment of Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00220610
• Other study ID #: CCMO03.3741/SH/P03.1231L
• Status: Recruiting
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: May 2004
• Est. completion date: December 2006

Study information

• Verified date: September 2005
• Source: St. Lucas Andreas Ziekenhuis Hospital
• Contact: Judith van der Riet, Drs.
• Phone: 0031-20-5108562
• Email: j.vanderriet[@]slaz.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Transcranial magnetic stimulation

Locations

Country	Name	City	State
Netherlands	st. Lucas Andreas Ziekenhuis/ Hospital	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
St. Lucas Andreas Ziekenhuis Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale)
Secondary	-Changes in anxiety
Secondary	-.Autonomic changes
Secondary	-.changes in the emotioneal attention, in the emotional memory en in de emotional recognition.
Secondary	-.Biochemical changes
Secondary	-.Changes in the EEG
Secondary	>> measured before tms and after (at T=0 and T=2)