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
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 April 14, 2014