Magnetic Stimulation Therapy for Treating Vascular Depression (rtms)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00044798|
Recruitment Status : Completed
First Posted : September 6, 2002
Last Update Posted : September 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder Depression||Procedure: Repetitive transcranial magnetic stimulation (rTMS) Drug: Citalopram Procedure: Sham rTMS||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Vascular Depression and Magnetic Stimulation Therapy|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||August 2008|
Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.
Procedure: Repetitive transcranial magnetic stimulation (rTMS)
Participants will receive 15 treatments of rTMS over 3 weeks.Drug: Citalopram
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.Procedure: Sham rTMS
Participants will receive 15 treatments of sham rTMS over 3 weeks.
- 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 ]
- Improvements in activities of daily living, quality of life, and cognitive function [ Time Frame: Measured at Week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044798
|United States, Iowa|
|University of Iowa Health Care|
|Iowa City, Iowa, United States, 52242-1087|