Magnetic Stimulation Therapy for Treating Vascular Depression - Full Text View

Purpose

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	Intervention	Phase
Depressive Disorder Depression	Procedure: Repetitive transcranial magnetic stimulation (rTMS) Drug: Citalopram Procedure: Sham rTMS	Phase III

MedlinePlus related topics:

Depression

Drug Information available for:

Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Vascular Depression and Magnetic Stimulation Therapy

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Improvements in activities of daily living, quality of life, and cognitive function [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	September 2001
Study Completion Date:	August 2008
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	51 Years to 89 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044798

Locations


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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

Responsible Party:	UIHC/Psychiatry ( Robert G. Robinson, MD )
Study ID Numbers:	R01 MH63405, DATR A4-GPX
First Received:	September 4, 2002
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00044798
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Aged

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Dexetimide

Depressive Disorder

Citalopram

Serotonin

Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Serotonin Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Antidepressive Agents, Second-Generation

Serotonin Uptake Inhibitors

Central Nervous System Agents

Pharmacologic Actions

Antidepressive Agents

ClinicalTrials.gov processed this record on November 19, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00044798