Magnetic Stimulation Therapy for Treating Vascular Depression

Depression Clinical Trial

— rtms  

Official title:

Vascular Depression and Magnetic Stimulation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044798
• Other study ID #: R01MH063405
• Secondary ID: R01MH063405DATR
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2002
• Last updated: September 26, 2013
• Start date: September 2001
• Est. completion date: August 2008

Study information

• Verified date: September 2013
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: August 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa Health Care	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Improvements in activities of daily living, quality of life, and cognitive function		Measured at Week 12	No