rTMS for PTSD Comorbid With Major Depressive Disorder

NCT02273063 | Completed Results

• 1 other identifier: 1404-005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Posttraumatic Stress Disorder; Major Depressive Disorder; Transcranial Magnetic Stimulation, Repetitive

Keywords

PTSD; MDD; TMS; 5Hz

Outcome Measures

Primary Outcomes (2)

• Total Score on PTSD Checklist for DSM-5 (PCL-5)

  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

  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)

Study Arms (1)

Transcranial Magnetic Stimulation

EXPERIMENTAL

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)

Interventions

Transcranial Magnetic Stimulation (TMS) DEVICE

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.

Also known as: Neuronetics' NeuroStar TMS Therapy System

Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Outpatients 18-70 years of age (inclusive)
• 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;
• Have a baseline score of "Moderately Ill" or worse on both the CGI-S and the PGI-S.
• 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);
• 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);
• If female and of child bearing potential, agree to use an acceptable method of birth control for the duration of the study treatment period
• Be willing and able to comply with all study related procedures and visits,
• Be capable of independently reading and understanding patient information materials and giving written informed consent.

You may not qualify if:

• Are pregnant or lactating or planning to become pregnant within the next three months.
• 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).
• 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;
• Current Axis 1 primary psychotic disorder, or bipolar I disorder, current alcohol and/or substance dependence or abuse within the past 1 month;
• Past treatment with TMS therapy
• 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.
• 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.

Sponsors & Collaborators

• Butler Hospital: lead
• Providence VA Medical Center: collaborator
• Neuronetics: collaborator

Study Sites (2)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Providence VA Medical Center

Providence, Rhode Island, 02908, United States

Location

Related Publications (2)

• Carpenter LL, Conelea C, Tyrka AR, Welch ES, Greenberg BD, Price LH, Niedzwiecki M, Yip AG, Barnes J, Philip NS. 5 Hz Repetitive transcranial magnetic stimulation for posttraumatic stress disorder comorbid with major depressive disorder. J Affect Disord. 2018 Aug 1;235:414-420. doi: 10.1016/j.jad.2018.04.009. Epub 2018 Apr 5.

  PMID: 29677606 DERIVED

• Philip NS, Barredo J, van 't Wout-Frank M, Tyrka AR, Price LH, Carpenter LL. Network Mechanisms of Clinical Response to Transcranial Magnetic Stimulation in Posttraumatic Stress Disorder and Major Depressive Disorder. Biol Psychiatry. 2018 Feb 1;83(3):263-272. doi: 10.1016/j.biopsych.2017.07.021. Epub 2017 Aug 8.

  PMID: 28886760 DERIVED

Related Links

• Online ahead of print article with all methods and results

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Director
• Organization: Neuromodulation Research Clinic

Linda_Carpenter_MD@Brown.edu

401-455-6200

Study Officials

• Linda L Carpenter, M.D.

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 23, 2014
• Study Start: October 1, 2014
• Primary Completion: April 22, 2016
• Study Completion: April 22, 2016
• Last Updated: October 4, 2018
• Results First Posted: October 4, 2018

Record last verified: 2018-10

Locations

US (2)