Magnetic Stimulation Therapy for Treating Vascular Depression (rtms)

September 26, 2013 updated by: University of Iowa

Vascular Depression and Magnetic Stimulation Therapy

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242-1087
        • University of Iowa Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive treatment with repetitive transcranial magnetic stimulation and citalopram.
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.
Active Comparator: 2
Participants will receive treatment with sham repetitive transcranial magnetic stimulation and citalopram.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured at Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvements in activities of daily living, quality of life, and cognitive function
Time Frame: Measured at Week 12
Measured at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 4, 2002

First Submitted That Met QC Criteria

September 5, 2002

First Posted (Estimate)

September 6, 2002

Study Record Updates

Last Update Posted (Estimate)

September 27, 2013

Last Update Submitted That Met QC Criteria

September 26, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH063405 (U.S. NIH Grant/Contract)
  • DATR A4-GPX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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