Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders

NCT00001545 | Completed Phase 2

• 2 other identifiers: 96008696-M-0086
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through your scalp and skull and generates a small electrical pulses in your brain. rTMS at lower intensities has helped some people with depression but we do not know what the results will be in your case using higher intensities, or whether you will be randomized to 3 weeks of high frequency (20 cycles er second), low frequency (1 cycle per second), or inactive (sham)rTMS. You will be assigned to receive one of these types of rTMS over the left front art of your brain five times per week for the three weeks. Each rTMS treatment session should take between 20-30 minutes of actual stimulation, but weekly ratings, memory testing, and blood sampling may require several hours per week. We will also ask you to have brain imaging procedures to see if these will predict response to high vs. low frequency rTMS. If you are randomized to the 3 weeks of sham rTMS, you will have the opportunity to receive one of the active stimulation frequencies for an additional 3 weeks. Responders to any phase will be offered an additional month of rTMS prior to study termination and recommendations of alternative treatments.

Conditions

Bipolar Disorder; Mood Disorder; Unipolar Depression

Keywords

Affective Disorders; Repetitive Transcranial Magnetic Stimulation; Mania; Bipolar Disorder; Depression; Unipolar Disorder; Unipolar Depression

Interventions

Magstim Super Rapid Magnetic Stimulator DEVICE

Cadwell MES-10 DEVICE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients will receive a psychiatric and physical examination by a qualified physician.
• Patients will be from 18 to 90 years of age and must give informed consent.
• Unipolar patients must be medication free to participate. Patients with bipolar disorder depression may be medication-free or on any combination (including monotherapy) of lithium, carbamazepine, and valproate. Inpatient monitoring will be provided when medically indicated.

You may not qualify if:

• General contraindications to rTMS or a current diagnosis of alcohol or substance abuse.
• Subjects having serious medical illnesses or meeting current psychoactive substance dependence will be excluded from entry.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Speer AM, Kimbrell TA, Wassermann EM, D Repella J, Willis MW, Herscovitch P, Post RM. Opposite effects of high and low frequency rTMS on regional brain activity in depressed patients. Biol Psychiatry. 2000 Dec 15;48(12):1133-41. doi: 10.1016/s0006-3223(00)01065-9.

  PMID: 11137053 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders; Depressive Disorder; Mania; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: May 1, 1996
• Study Completion: July 1, 2006
• Last Updated: July 13, 2006

Record last verified: 2006-07

Locations

US (1)