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Completed

NCT Number: NCT00044798

Magnetic Stimulation Therapy for Treating Vascular Depression

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).

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Key information

Conditions

Depressive Disorder Behavior Behavioral Symptoms Depression Mental Disorders Mood Disorders

Age range

51 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Iowa Health Care

Iowa City, Iowa, 52242-1087, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Procedure

Participants will receive 15 treatments of rTMS over 3 weeks.

Citalopram

Drug

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

sham rTMS

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Improvements in activities of daily living, quality of life, and cognitive function

    Time frame: Measured at Week 12

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Vascular Depression and Magnetic Stimulation Therapy

Acronym: rtms

Important dates

Study start
2001
Primary completion
2007
Study completion
2008
First posted
Sep 6, 2002
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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