Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment for Depression

NCT01115699 | Terminated Results

• 1 other identifier: 10-000401
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The study will systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin reuptake inhibitor (SSRI) followed by a serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response.

Conditions

Depression

Keywords

Depression; rTMS

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Rating Scale for Depression (HRS-D17)

  The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.

  baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks

Secondary Outcomes (1)

• Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)

  baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks

Study Arms (1)

Repetitive Transcranial Magnetic Stimulation

EXPERIMENTAL

All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

Active 10 Hz rTMS will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) with an intensity of 120% motor threshold. The L-DLPFC location is defined as that area 5 cm anterior to the motor cortex for activation of abductor pollicis brevis. Subjects will receive a total of 3000 stimuli per session. The TMS trains are 4 seconds on and 26 seconds off for a total of 37 1/2 minutes. Treatment will occur 5 days per week for up to six weeks. Subjects will be monitored during rTMS for any side effects or adverse events.

Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects whose depressive symptoms have not remitted during their participation in the "Pharmacokinetics and Pharmacodynamics of Citalopram and Escitalopram" study or the "Pharmacokinetics and Pharmacodynamics of Duloxetine" study
• Must be able to continue to take same dose of duloxetine through the course of the study

You may not qualify if:

• A history of failure for respond to Electroconvulsive Therapy (ECT)
• Any metal in the head (except in mouth)
• Implanted medication pump or cardiac pacemaker
• Have had prior brain surgery
• Have unprovoked seizure disorder or family history of treatment resistant epilepsy
• Pregnancy
• Psychiatric hospitalization within the past two weeks
• Suicide attempt with hospitalization within past three months

Sponsors & Collaborators

• Mayo Clinic: lead
• Neuronetics: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

This study was stopped early due to funding constraints and recruitment was slower than was expected.

Results Point of Contact

• Title: Michelle Skime, Supervisor - Senior Clinical Research Coordinator
• Organization: Mayo Clinic

skime.michelle@mayo.edu

507-255-0501

Study Officials

• David Mrazek, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David Mrazek, M.D.

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: April 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 13, 2013
• Results First Posted: December 13, 2013

Record last verified: 2013-10

Locations

US (1)