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Magnetic Stimulation Therapy for Treating Vascular Depression (rtms)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044798
First Posted: September 6, 2002
Last Update Posted: September 27, 2013
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of Iowa
September 4, 2002
September 6, 2002
September 27, 2013
September 2001
March 2007   (Final data collection date for 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 ]
Not Provided
Complete list of historical versions of study NCT00044798 on ClinicalTrials.gov Archive Site
Improvements in activities of daily living, quality of life, and cognitive function [ Time Frame: Measured at Week 12 ]
Not Provided
Not Provided
Not Provided
 
Magnetic Stimulation Therapy for Treating Vascular Depression
Vascular Depression and Magnetic Stimulation Therapy
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).

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Depressive Disorder
  • Depression
  • 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.
  • Procedure: Sham rTMS
    Participants will receive 15 treatments of sham rTMS over 3 weeks.
  • Experimental: 1
    Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.
    Interventions:
    • Procedure: Repetitive transcranial magnetic stimulation (rTMS)
    • Drug: Citalopram
  • Active Comparator: 2
    Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
    Interventions:
    • Drug: Citalopram
    • Procedure: Sham rTMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
August 2008
March 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
51 Years to 89 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00044798
R01MH063405( U.S. NIH Grant/Contract )
R01MH063405 ( U.S. NIH Grant/Contract )
DATR A4-GPX
Yes
Not Provided
Not Provided
Robert G. Robinson, MD, UIHC/Psychiatry
University of Iowa
National Institute of Mental Health (NIMH)
Not Provided
University of Iowa
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP