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Magnetic Stimulation Therapy for Treating Vascular Depression (rtms)

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ClinicalTrials.gov Identifier: NCT00044798
Recruitment Status : Completed
First Posted : September 6, 2002
Last Update Posted : September 27, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Depressive Disorder Depression Procedure: Repetitive transcranial magnetic stimulation (rTMS) Drug: Citalopram Procedure: Sham rTMS Phase 3

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  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vascular Depression and Magnetic Stimulation Therapy
Study Start Date : September 2001
Primary Completion Date : March 2007
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Citalopram
U.S. FDA Resources

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.



Primary Outcome Measures :
  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 Outcome Measures :
  1. Improvements in activities of daily living, quality of life, and cognitive function [ Time Frame: Measured at Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044798


Locations
United States, Iowa
University of Iowa Health Care
Iowa City, Iowa, United States, 52242-1087
Sponsors and Collaborators
University of Iowa
National Institute of Mental Health (NIMH)

Responsible Party: Robert G. Robinson, MD, UIHC/Psychiatry
ClinicalTrials.gov Identifier: NCT00044798     History of Changes
Other Study ID Numbers: R01MH063405 ( U.S. NIH Grant/Contract )
DATR A4-GPX
First Posted: September 6, 2002    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013

Keywords provided by University of Iowa:
Aged

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents