REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION

Phase 2

• Conditions: Depression

• Registration Number: NCT00220610
• Lead Sponsor: St. Lucas Andreas Ziekenhuis Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Last Update Submitted: 2005-09-13
• Study First Posted: 2005-09-22
• Last Update Posted: 2005-09-22
• Study Completion: 2006-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
-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)

Trial Locations

Locations (1)

st. Lucas Andreas Ziekenhuis/ Hospital; 🇳🇱 Amsterdam, Netherlands