- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00044798
Magnetic Stimulation Therapy for Treating Vascular Depression (rtms)
Vascular Depression and Magnetic Stimulation Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242-1087
- University of Iowa Health Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.
|
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.
|
Active Comparator: 2
Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
|
After completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks.
Participants will receive 15 treatments of sham rTMS over 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Measured at Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvements in activities of daily living, quality of life, and cognitive function
Time Frame: Measured at Week 12
|
Measured at Week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- R01MH063405 (U.S. NIH Grant/Contract)
- DATR A4-GPX
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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