Magnetic Stimulation Therapy for Treating Vascular Depression (rtms)
Primary Purpose
Depressive Disorder, Depression
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation (rTMS)
Citalopram
Sham rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring Aged
Eligibility Criteria
Inclusion Criteria: 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
Sites / Locations
- University of Iowa Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.
Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
Outcomes
Primary Outcome Measures
Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy
Secondary Outcome Measures
Improvements in activities of daily living, quality of life, and cognitive function
Full Information
NCT ID
NCT00044798
First Posted
September 4, 2002
Last Updated
September 26, 2013
Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00044798
Brief Title
Magnetic Stimulation Therapy for Treating Vascular Depression
Acronym
rtms
Official Title
Vascular Depression and Magnetic Stimulation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
Vascular depression is a condition that typically affects the elderly and is associated with small vascular lesions. It is more resistant to treatment and has a poorer outcome than nonvascular depression. By altering excitability in the cortical area of the brain, rTMS may be an effective treatment neuropsychiatric conditions, particularly depression.
Participants in this study will be randomly assigned to 15 treatments of either rTMS or sham rTMS for 3 weeks. Following treatment, participants will receive citalopram for 9 weeks. Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy will be measured. Improvements in activities of daily living, quality of life, and cognitive function will also be also measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depression
Keywords
Aged
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
Intervention Type
Procedure
Intervention Name(s)
Repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
Participants will receive 15 treatments of rTMS over 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Citalopram
Intervention Description
After completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks.
Intervention Type
Procedure
Intervention Name(s)
Sham rTMS
Intervention Description
Participants will receive 15 treatments of sham rTMS over 3 weeks.
Primary Outcome Measure Information:
Title
Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy
Time Frame
Measured at Week 12
Secondary Outcome Measure Information:
Title
Improvements in activities of daily living, quality of life, and cognitive function
Time Frame
Measured at Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Facility Information:
Facility Name
University of Iowa Health Care
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1087
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Magnetic Stimulation Therapy for Treating Vascular Depression
We'll reach out to this number within 24 hrs