rTMS for PTSD Comorbid With Major Depressive Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02273063|
Recruitment Status : Completed
First Posted : October 23, 2014
Results First Posted : October 4, 2018
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder Major Depressive Disorder Transcranial Magnetic Stimulation, Repetitive||Device: Transcranial Magnetic Stimulation (TMS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||5Hz Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder Comorbid With Major Depressive Disorder|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||April 22, 2016|
|Actual Study Completion Date :||April 22, 2016|
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 Name: Neuronetics' NeuroStar TMS Therapy System
- 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.
- 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.
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): NCT02273063
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Providence VA Medical Center|
|Providence, Rhode Island, United States, 02908|
|Principal Investigator:||Linda L Carpenter, M.D.||Butler Hospital|