NCT00220610

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 depression

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 22, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • -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

  • +1 more secondary outcomes

Interventions

Transcranial magnetic stimulationDEVICE

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

st. Lucas Andreas Ziekenhuis/ Hospital

Amsterdam, 1061 AE, Netherlands

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • G.F Koerselman, prof. dr.

    st Lucas Andreas Ziekenhuis

    STUDY DIRECTOR

Central Study Contacts

Judith van der Riet, Drs.

CONTACT

0031-20-5108562j.vanderriet@slaz.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

May 1, 2004

Study Completion

December 1, 2006

Last Updated

September 22, 2005

Record last verified: 2005-09

Locations

NL(1)