Posttraumatic Stress DisorderNCT02273063
rTMS for PTSD Comorbid With Major Depressive Disorder
A study testing Transcranial Magnetic Stimulation (TMS) in people with Posttraumatic Stress Disorder and Major Depressive Disorder, run by Butler Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Major Depressive Disorder, Transcranial Magnetic Stimulation, Repetitive
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to 22 Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Butler Hospital
Providence, Rhode Island, 02906
Providence VA Medical Center
Providence, Rhode Island, 02908
About this study
Official title: 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder, Major Depressive Disorder, Transcranial Magnetic Stimulation, Repetitive
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Keywords
- PTSD, MDD, TMS, 5Hz
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
Also called Neuronetics' NeuroStar TMS Therapy System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to final TMS session (up to 40 sessions over up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion22 Apr 2016
- Study completion22 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Providence VA Medical Center, Neuronetics
- Responsible party
- Sponsor
- Investigators
- Linda L Carpenter, M.D., Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273063
- Sponsor's protocol ID
- 1404-005
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2014
- Last updated
- 4 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29677606Philip 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.
PubMed 28886760
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5Hz Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder Comorbid With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02273063
- Acronym / sponsor ID
- 1404-005
- Conditions
- Posttraumatic Stress Disorder, Major Depressive Disorder, Transcranial Magnetic Stimulation, Repetitive
- Keywords
- PTSD, MDD, TMS, 5Hz
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- Providence VA Medical Center, Neuronetics
- Study start
- Oct 2014
- Primary completion
- 22 Apr 2016 (actual)
- Study completion
- 22 Apr 2016 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Posted 4 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Device: Transcranial Magnetic Stimulation (TMS)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)Also: Neuronetics' NeuroStar TMS Therapy SystemUp 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. | Device | Transcranial Magnetic Stimulation |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29677606Carpenter 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.
- Derived from this study: PubMed 28886760Philip 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.
- Online ahead of print article with all methods and resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda L Carpenter, M.D. principal investigator
Butler Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Posttraumatic Stress Disorder and Major Depressive Disorder, run by Butler Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02273063, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.