rTMS for PTSD Comorbid With Major Depressive Disorder

October 2, 2018 updated by: Butler Hospital

5Hz Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder Comorbid With Major Depressive Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
      • Providence, Rhode Island, United States, 02908
        • Providence VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. To ensure subjects can safely receive rTMS, eligible subjects must meet all established screening criteria for safety during MRI (magnetic resonance imaging), since MRI involves magnetic fields at similar intensity to those emitted from the rTMS treatment coil. These are conservative measures require a patient not having the following (unless MRI-safe): Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord;
  2. Outpatients 18-70 years of age (inclusive)
  3. Meet DSM-IV criteria for MDD (recurrent or single episode chronic) and PTSD (acute or chronic) 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 and adequate treatment in the current episode, OR have demonstrated intolerance to at least one antidepressant medication as part of attempted treatment in the current episode of illness (i.e., meet FDA labeling requirements for administration of rTMS for depression);
  6. Be on a stable psychotropic regimen for at least six weeks (42 days) prior to screening, or no psychotropic medication at all, and be willing to maintain the current regimen and dosing for the duration of the study (unless medical necessary to make changes with notification of research staff);
  7. If female and of child bearing potential, agree to use an acceptable method of birth control 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 materials and giving written informed consent.

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 with documented evidence of brain injury (including brain atrophy).
  3. Current (or past if appropriate) significant neurological disorder, or lifetime history 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 alcohol and/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 the Investigator'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 opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Magnetic Stimulation
Stimulation at pulse frequency of 5Hz delivered over L DLPFC. Intensity: 120% of Motor Threshold, 5 Sec Train, 14 Sec Inter-Train Interval, Frequency: 5Hz, Total Pulses: 3000/session. Sessions delivered once/day on weekdays for up to 40 sessions.
Device: Transcranial Magnetic Stimulation (TMS)
Up to 40 sessions of TMS delivered with the first 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper schedule over 3 weeks. Treatment is adjunct to ongoing stable pharmacotherapy.
Other Names:
  • Neuronetics' NeuroStar TMS Therapy System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Score on PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Baseline to final TMS session (up to 40 sessions over up to 8 weeks)
This self-report scale is called: "PTSD Checklist for DSM-5" (abbreviated PCL-5) (see https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp). Total PCL-5 score ranges from 0 to 80. Analysis of treatment effect on symptom severity will be evaluated by change in PCL-5 total score from baseline (pre-TMS) to endpoint (post-TMS)(or LOCF); Paired t-test compares the mean total PCL-score for the group at the two time points. A higher total score on the PCL-5 scale corresponds with more severe PTSD symptoms than a lower total score. A greater change from baseline to endpoint would correspond with better treatment outcome.
Baseline to final TMS session (up to 40 sessions over up to 8 weeks)
Total Score on Inventory of Depressive Symptomatology, Self-Report (IDS-SR) Scale
Time Frame: Baseline to final TMS session (up to 40 sessions over up to 8 weeks)
This self-report scale is called "Inventory of Depressive Symptomatology, Self-Report" (Abbreviated IDS-SR). IDS-SR Total Scores Range from 0 to 84, with a higher score reflecting greater depressive symptom severity. Paired t-test compares the change in mean total IDS-SR score from baseline (pre-TMS) to endpoint (last TMS session) or LOCF. A greater change reflects a better outcome than lesser change.
Baseline to final TMS session (up to 40 sessions over up to 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

Neuronetics
Providence VA Medical Center

Investigators

  • Principal Investigator: Linda L Carpenter, M.D., Butler Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

April 22, 2016

Study Completion (Actual)

April 22, 2016

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on Transcranial Magnetic Stimulation (TMS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe