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Magnetic Stimulation Therapy for Treating Vascular Depression (rtms)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00044798
First received: September 4, 2002
Last updated: August 20, 2008
Last verified: August 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vascular Depression and Magnetic Stimulation Therapy

Resource links provided by NLM:

MedlinePlus related topics: Depression
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
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.

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

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

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

ClinicalTrials.gov processed this record on May 22, 2013