Magnetic Stimulation Therapy for Treating Vascular Depression

Phase 3

Completed

• Conditions: Depressive Disorder; Depression
• Interventions: Procedure: Repetitive transcranial magnetic stimulation (rTMS); Drug: Citalopram; Procedure: Sham rTMS

• Registration Number: NCT00044798
• Lead Sponsor: University of Iowa

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 Timeline

• Study Start: 2001-09
• Study First Submitted: 2002-09-04
• Study First Submitted QC: 2002-09-05
• Study First Posted: 2002-09-06
• Primary Completion: 2007-03
• Study Completion: 2008-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-26
• Last Update Posted: 2013-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Repetitive transcranial magnetic stimulation (rTMS)	Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.
2	Citalopram	Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
2	Sham rTMS	Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
1	Citalopram	Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.

Primary Outcome Measures

Name	Time	Method
Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy	Measured at Week 12

Secondary Outcome Measures

Name	Time	Method
Improvements in activities of daily living, quality of life, and cognitive function	Measured at Week 12

Trial Locations

Locations (1)

University of Iowa Health Care; 🇺🇸 Iowa City, Iowa, United States