Magnetic Stimulation Therapy for Treating Vascular Depression - Full Text View

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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

No publications provided

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

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

Aged

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Dexetimide

Antidepressive Agents
Depression
Depressive Disorder
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009