Magnetic Stimulation Therapy for Treating Vascular Depression - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	Related Studies

Magnetic Stimulation Therapy for Treating Vascular Depression (rtms)

This study has been completed.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Magnetic Stimulation Therapy for Treating Vascular Depression
Official Title ^†	Vascular Depression and Magnetic Stimulation Therapy
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.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure ^†	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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure ^†	Improvements in activities of daily living, quality of life, and cognitive function [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
Condition ^†	Depressive Disorder Depression
Intervention ^†	Procedure: Repetitive transcranial magnetic stimulation (rTMS) Drug: Citalopram Procedure: Sham rTMS
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	132
Start Date ^†	September 2001
Completion Date	August 2008
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
Gender	Both
Ages	51 Years to 89 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00044798
Organization ID	R01 MH63405
Secondary IDs ^††	DATR A4-GPX
Study Sponsor ^†	National Institute of Mental Health (NIMH)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	August 2008
First Received Date ^†	September 4, 2002
Last Updated Date	August 20, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.