Magnetic Stimulation Therapy for Treating Vascular Depression - Tabular View

Tracking Information
First Received Date ^ICMJE	September 4, 2002
Last Updated Date	August 20, 2008
Start Date ^ICMJE	September 2001
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 17, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00044798 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 17, 2008)	Improvements in activities of daily living, quality of life, and cognitive function [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Magnetic Stimulation Therapy for Treating Vascular Depression
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Depressive Disorder Depression
Intervention ^ICMJE	Procedure: Repetitive transcranial magnetic stimulation (rTMS) Drug: Citalopram Procedure: Sham rTMS
Study Arms / Comparison Groups	Experimental: Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram. Active Comparator: Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	132
Completion Date	August 2008
Primary Completion Date	March 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00044798
Responsible Party	Robert G. Robinson, MD, UIHC/Psychiatry
Study ID Numbers ^ICMJE	R01 MH63405, DATR A4-GPX
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP