rTMS for PTSD Comorbid With Major Depressive Disorder

Last updated: October 2, 2018
Sponsor: Butler Hospital
Overall Status: Completed

Phase

N/A

Condition

Depression

Affective Disorders

Post-traumatic Stress Disorders

Treatment

N/A

Clinical Study ID

NCT02273063
1404-005
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to see how well a treatment called "Repetitive Transcranial Magnetic Stimulation" works for patients who struggle with symptoms of both posttraumatic stress disorder and major depressive disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. To ensure subjects can safely receive rTMS, eligible subjects must meet allestablished screening criteria for safety during MRI (magnetic resonance imaging),since MRI involves magnetic fields at similar intensity to those emitted from the rTMStreatment coil. These are conservative measures require a patient not having thefollowing (unless MRI-safe): Cardiac pacemaker, implanted device (deep brainstimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinalcord;

  2. Outpatients 18-70 years of age (inclusive)

  3. Meet DSM-IV criteria for MDD (recurrent or single episode chronic) and PTSD (acute orchronic) at the time of the screening and baseline visits;

  4. Have a baseline score of "Moderately Ill" or worse on both the CGI-S and the PGI-S.

  5. Have failed at least one antidepressant medication trial as part of definitive andadequate treatment in the current episode, OR have demonstrated intolerance to atleast one antidepressant medication as part of attempted treatment in the currentepisode of illness (i.e., meet FDA labeling requirements for administration of rTMSfor depression);

  6. Be on a stable psychotropic regimen for at least six weeks (42 days) prior toscreening, or no psychotropic medication at all, and be willing to maintain thecurrent regimen and dosing for the duration of the study (unless medical necessary tomake changes with notification of research staff);

  7. If female and of child bearing potential, agree to use an acceptable method of birthcontrol for the duration of the study treatment period

  8. Be willing and able to comply with all study related procedures and visits,

  9. Be capable of independently reading and understanding patient information materialsand giving written informed consent.

Exclusion

Exclusion Criteria:

  1. Are pregnant or lactating or planning to become pregnant within the next three months.

  2. Have a lifetime history of loss of consciousness due to head injury for greater than 10 minutes, or any lifetime history of loss of consciousness due to a head injury withdocumented evidence of brain injury (including brain atrophy).

  3. Current (or past if appropriate) significant neurological disorder, or lifetimehistory of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d)cerebral aneurysm;

  4. Current Axis 1 primary psychotic disorder, or bipolar I disorder, current alcoholand/or substance dependence or abuse within the past 1 month;

  5. Past treatment with TMS therapy

  6. Have active suicidal intent or plan as detected on screening assessments, or in theInvestigator's opinion, is likely to attempt suicide within the next six months.

  7. Demonstrate the presence of any other condition or circumstance that, in the opinionof the investigator, has the potential to prevent study completion and/or to have aconfounding effect on outcome assessments.

Study Design

Total Participants: 40
Study Start date:
October 01, 2014
Estimated Completion Date:
April 22, 2016

Study Description

This study aims to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for adults with comorbid posttraumatic stress disorder (PTSD) and major depressive disorder (MDD). Although standard rTMS uses stimulations delivered to the left prefrontal cortex at 10 pulses per second, prior work has shown that other stimulation frequencies may work for both PTSD and MDD. In this study, we examine the efficacy of left-sided 5Hz in patients with PTSD and MDD, hypothesizing that this lower frequency will improve PTSD and MDD symptoms.

Connect with a study center

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Providence VA Medical Center

    Providence, Rhode Island 02908
    United States

    Site Not Available

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