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Trial record 7 of 232 for:    Not yet recruiting Studies | Depression

Investigational TMS Treatment for Depression

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ClinicalTrials.gov Identifier: NCT03175887
Recruitment Status : Not yet recruiting
First Posted : June 5, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Paul Holtzheimer, Dartmouth-Hitchcock Medical Center

Brief Summary:
This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation at the forehead versus the left side of the head for treatment of Treatment Resistant Depression.

Condition or disease Intervention/treatment Phase
Depression Treatment Resistant Depression Device: TMS Not Applicable

Detailed Description:
While transcranial magnetic stimulation (TMS) to the left dorsolateral prefrontal cortex (DLPFC) is an FDA approved treatment for depression, a growing and converging database suggests the medial prefrontal cortex (MPFC) may be even more critical to the neurobiology of depression and antidepressant treatment response. This study will compare the efficacy of high frequency transcranial madntic stimulation on these two sections of the brain.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dorsolateral Versus Medial Prefrontal TMS for Depression
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm
Participants will receive TMS. They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex.
Device: TMS
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.

Treatment Arm

After the experimental arm, if a patient was randomized to the medial prefrontal cortex during the experimental arm and it did not work for them, they have the option of returning for a session of TMS to the FDA-approved dorsolateral prefrontal cortex.

If they were assigned to the dorsolateral prefrontal cortex, they are not eligible to return for another set of treatment.

Device: TMS
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.




Primary Outcome Measures :
  1. Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale [ Time Frame: Change from baseline Hamilton-17 score to follow-up visit at 1 week after final TMS intervention. ]
    Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21-70 years old
  • inadequate response to one current antidepressant medication
  • currently depressed

Exclusion Criteria:

  • psychiatric comorbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175887


Contacts
Contact: Shannon H Malloy, M.A. 6036504914 mood@dartmouth.edu

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Shannon H Malloy, M.A.    603-650-4914    mood@dartmouth.edu   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center

Responsible Party: Paul Holtzheimer, Director of Mood Disorders Service, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03175887     History of Changes
Other Study ID Numbers: D17107
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Paul Holtzheimer, Dartmouth-Hitchcock Medical Center:
depression
trd
treatment-resistant depression
TMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders