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

This study has been terminated.
(Stopped due to funding constraints and recruitment was slower than was expected)
Sponsor:
Collaborator:
Neuronetics
Information provided by (Responsible Party):
David Mrazek, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01115699
First received: April 30, 2010
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Depression
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as Adjuvant Treatment in Patients With Non-remitting Depression: Third Stage of Citalopram/Escitalopram Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Hamilton Rating Scale for Depression (HRS-D17) [ Time Frame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16) [ Time Frame: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks ] [ Designated as safety issue: No ]

    The QIDS-C16 measures 16 factors across 9 different criterion domains for major depression. Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following:the highest number from questions 1-4 + the number from question 5 + the highest number from questions 6-9 + the total of each question from 10-14 + the highest number from questions 15-16.

    Screening test scoring ranges:

    • 0-5, No Depression Likely
    • 6-10, Possibly Mildly Depressed
    • 11-15, Moderate Depression
    • 16-20, Severe Depression
    • 21 or Over, Very Severe Depression


Enrollment: 2
Study Start Date: April 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Repetitive Transcranial Magnetic Stimulation
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)
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.

Detailed Description:

This is the first study of its kind to systematically investigate the use of repetitive transcranial magnetic stimulation (rTMS) in non-remitters of a selective serotonin-reuptake inhibitor (SSRI) followed by an serotonin-norepinephrine reuptake inhibitor (SNRI) trial with the capacity to identify gene variants that predict rTMS response. The study is similar in design to the STAR*D study in that it will be the third treatment stage for a study of subjects with major depressive disorder (MDD). rTMS is a novel intervention which was FDA approved for treatment of MDD in October 2008 and was not clinically available at the time of the STAR*D study.

The primary aim of this pilot study is to provide 10 Hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in individuals who have not had a remission of their depressive symptoms after an 8 week trial of an SSRI (citalopram or escitalopram) followed by an 8 week trial of an SNRI, duloxetine and identify gene variants associated with improvement of their depressive symptoms.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115699

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Neuronetics
Investigators
Principal Investigator: David Mrazek, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: David Mrazek, David Mrazek, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01115699     History of Changes
Other Study ID Numbers: 10-000401
Study First Received: April 30, 2010
Results First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Depression
rTMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014