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Magnetic Stimulation Therapy for Treating Vascular Depression

Vascular Depression and Magnetic Stimulation Therapy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00044798
Acronym
rtms
Enrollment
132
Registered
2002-09-06
Start date
2001-09-30
Completion date
2008-08-31
Last updated
2013-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Depressive Disorder

Keywords

Aged

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.

Interventions

PROCEDURERepetitive transcranial magnetic stimulation (rTMS)

Participants will receive 15 treatments of rTMS over 3 weeks.

DRUGCitalopram

After completing treatment with rTMS or sham rTMS, participants will take citalopram for 9 weeks.

PROCEDURESham rTMS

Participants will receive 15 treatments of sham rTMS over 3 weeks.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Iowa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
51 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophyMeasured at Week 12

Secondary

MeasureTime frame
Improvements in activities of daily living, quality of life, and cognitive functionMeasured at Week 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026