Magnetic Stimulation Therapy for Treating Vascular Depression

NCT ID: NCT00044798

Last Updated: 2013-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2008-08-31

Brief Summary

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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

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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.

Conditions

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Depressive Disorder Depression

Keywords

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Aged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type PROCEDURE

Participants will receive 15 treatments of rTMS over 3 weeks.

Citalopram

Intervention Type DRUG

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

2

Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.

Group Type ACTIVE_COMPARATOR

Citalopram

Intervention Type DRUG

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

Sham rTMS

Intervention Type PROCEDURE

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

Interventions

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Repetitive transcranial magnetic stimulation (rTMS)

Participants will receive 15 treatments of rTMS over 3 weeks.

Intervention Type PROCEDURE

Citalopram

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

Intervention Type DRUG

Sham rTMS

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

51 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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UIHC/Psychiatry

Locations

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University of Iowa Health Care

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH063405

Identifier Type: NIH

Identifier Source: secondary_id

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DATR A4-GPX

Identifier Type: -

Identifier Source: secondary_id

R01MH063405

Identifier Type: NIH

Identifier Source: org_study_id

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