Magnetic Stimulation Therapy for Treating Vascular Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vascular Depression and Magnetic Stimulation Therapy

Conditions
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Depressive Disorder, Depression

Intervention / Treatment
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* Procedure: Repetitive transcranial magnetic stimulation (rTMS)
* Drug: Citalopram
* Procedure: Sham rTMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 51 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram. | Procedure: Repetitive transcranial magnetic stimulation (rTMS)<br>* Participants will receive 15 treatments of rTMS over 3 weeks.<br>Drug: Citalopram<br>* After completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks.<br>|
| Active Comparator: 2<br>Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram. | Drug: Citalopram<br>* After completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks.<br>Procedure: Sham rTMS<br>* Participants will receive 15 treatments of sham rTMS over 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in activities of daily living, quality of life, and cognitive function |  | Measured at Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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