Study Stopped
Too few patients included
The Antidepressant Effect of Right Temporal Low Frequency rTMS Compared to Sham
1 other identifier
interventional
10
1 country
1
Brief Summary
The aim of the present study is to compare the antidepressant effect of low frequency rTMS applied over the right temporal cortex with sham stimulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMarch 15, 2019
March 1, 2019
2 years
January 24, 2008
March 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The total 17-item score on the Hamilton scale for depression
semistructured interview scale.
4 weeks of treatment and 4 weeks of follow-up
Study Arms (2)
repetitive transcranial magnetic stimulation
ACTIVE COMPARATORLow frequency ( 1 HZ) rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval.
Placebo stimulation
SHAM COMPARATORSham- rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval.
Interventions
Right temporal low frequency (1 hz) rTMS.
Eligibility Criteria
You may qualify if:
- Inpatients admitted to Århus university Hospital , Risskov or outpatients from the psychiatry district centres or practising specialist in the area.
- Moderate - severe depression according to ICD-10/ DSM-IVR
- Age 18-80 years
- Total Hamilton score ( 17-items) of ≥ 18 or subscale score ≥ 9
- Right handed
You may not qualify if:
- Organic brain disease
- Epilepsy in growing age
- Metallic objects as the result of a chest or Brain surgery
- Cardiac pacemakers
- Somatic diseases associated with brain dysfunction
- Pregnancy
- Suicide risk of severe degree
- Severe agitation or delirium
- Alcohol and drug dependency
- Ongoing Electroconvulsive treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Aarhus, Risskov
Aarhus, Risskov, 8240, Denmark
Related Publications (1)
Klein E, Kreinin I, Chistyakov A, Koren D, Mecz L, Marmur S, Ben-Shachar D, Feinsod M. Therapeutic efficacy of right prefrontal slow repetitive transcranial magnetic stimulation in major depression: a double-blind controlled study. Arch Gen Psychiatry. 1999 Apr;56(4):315-20. doi: 10.1001/archpsyc.56.4.315.
PMID: 10197825BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Poul Erik B Hansen, consultant
University Hospital og Aarhus, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 25, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
March 15, 2019
Record last verified: 2019-03