Magnetic Stimulation Therapy for Treating Vascular Depression
rtms
Vascular Depression and Magnetic Stimulation Therapy
2 other identifiers
interventional
132
1 country
1
Brief Summary
This 12-week study will evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) of the brain, followed by citalopram (Celexa®), for treatment of depression associated with small vascular lesions in the brain (vascular depression).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2001
Longer than P75 for phase_3
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
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 4, 2002
CompletedFirst Posted
Study publicly available on registry
September 6, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedSeptember 27, 2013
September 1, 2013
5.5 years
September 4, 2002
September 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy
Measured at Week 12
Secondary Outcomes (1)
Improvements in activities of daily living, quality of life, and cognitive function
Measured at Week 12
Study Arms (2)
1
EXPERIMENTALParticipants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.
2
ACTIVE COMPARATORParticipants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
Interventions
Participants will receive 15 treatments of rTMS over 3 weeks.
After completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks.
Eligibility Criteria
You may qualify if:
- DSM-IV diagnosis of unipolar major or minor depressive disorder
- Hamilton Depression Rating Scale score of at least 18
- Depression that is associated with cerebrovascular disease
- Failed at least 1 treatment for vascular depression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Iowalead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Iowa Health Care
Iowa City, Iowa, 52242-1087, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 4, 2002
First Posted
September 6, 2002
Study Start
September 1, 2001
Primary Completion
March 1, 2007
Study Completion
August 1, 2008
Last Updated
September 27, 2013
Record last verified: 2013-09