PTSD - Post Traumatic Stress DisorderPhase 2ONE-P_FRNCT07773935
ONE-P TMS First Responders
A Phase 2 study testing D-Cycloserine (DCS) and Intermittent Theta Burst Stimulation (iTBS) in people with PTSD - Post Traumatic Stress Disorder, run by Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA at 1 site in Canada.
Trial summary
The aim of this study is to examine the feasibility and tolerability of a one-day protocol of repetitive transcranial magnetic stimulation with D-cycloserine (DCS) as an augmentation strategy in first responders who have PTSD. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- D-Cycloserine (DCS) and Intermittent Theta Burst Stimulation (iTBS)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 1 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- are outpatients between the ages of 19-60;
- are voluntary and competent to consent;
- are first responders (active, on leave or retired);
- have DSM-5 diagnosis of PTSD with a CAPS for DSM-5 (CAPS-5) score ≥ 25;
- 17-item Hamilton Depression Rating Scale score ≤ 23;
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
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- if participating in psychotherapy, must have been in stable treatment for at least 1 month prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;
- able to adhere to the treatment schedule;
- Pass the TMS adult safety screening (TASS) questionnaire, and the MRI safety screening.
Who cannot join
- have a Severe Substance Use Disorder (except tobacco) within the last three (3) months;
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;
- have active suicidal intent;
- are pregnant;
- have a lifetime MINI diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms;
- have a MINI diagnosis of OCD, or mood disorder that is assessed by a study investigator to be primary and causing greater impairment than PTSD;
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- have a diagnosis of any personality disorder, assessed by a study investigator to be primary and causing greater impairment than MDD;
- have failed a course of ECT in the current episode or previous episode;
- have received rTMS for any previous indication;
- have any significant neurological disorder, history of seizure disorder (except those therapeutically induced by ECT), or any significant head trauma with clear radiological evidence of cerebrovascular injury on imaging;
- have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- clinically significant laboratory abnormality, in the opinion of the one of the principal investigators or study physicians (including but not limited to abnormal blood urea nitrogen (BUN), creatinine, estimated glomerular filtration rate (eGFR));
- currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy;
- currently take dicumarol, gingko biloba, isoniazid, ethionamide, fluphenazine, metrizamide, tramadol, warfarin due to potential interactions with D-Cycloserine;
- planned vaccination with Bacille Calmette-Guérin, cholera or typhoid or planned imaging procedure with an injectable die, within one week following the treatment days, due to potential interactions with DCS.
- allergy to DCS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
Vancouver, British Columbia, V6T 2A1
Amanda Ding, (604)-822-7308, ninet.lab@ubc.ca
Fidel Vila-Rodriguez
About this study
Official title: One-day rTMS + D-cycloserine to Treat PTSD in First Responders
The aim of this study is to examine the feasibility and tolerability of a one-day protocol of repetitive transcranial magnetic stimulation with D-cycloserine (DCS) as an augmentation strategy in first responders who have PTSD.
Read the detailed description
In this feasibility and tolerability trail, 50 patients with PTSD will be recruited at UBC. Patients will be randomised to receive either aiTBS plus DCS or aiTBS plus placebo DCS. The primary outcome is to evaluate the feasibility and tolerability of active aiTBS plus D-Cycloserine (DCS) versus active aiTBS plus placebo-DCS, using a one-day regimen of 15 treatment sessions, in active military personnel or veterans who suffer PTSD. A secondary aim is to explore preliminary signal of clinical efficacy of active aiTBS plus D-Cycloserine (DCS) on the primary outcome to inform sample size calculation for a definitive trial.
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- D-Cycloserine (DCS), Placebo, Intermittent Theta Burst Stimulation (iTBS)
- Keywords
- Transcranial Magnetic Stimulation, iTBS, PTSD, Post Traumatic Stress Disorder, Neuroplastogen
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-Cycloserine (DCS)Drug
Participants randomized to the active treatment arm will receive DCS 125 mg orally, administered as one capsule around one hour before active aiTBS treatment.
PlaceboDrug
Participants randomized to the placebo arm will receive one matched placebo capsule administered orally at the same time point and according to the same procedures as the active investigational product.
Intermittent Theta Burst Stimulation (iTBS)Device
rTMS will employ the MagPro X100/R30 stimulator (MagVenture, Farum, Denmark) equipped with the B70 coil. A scalp heuristic will be used to localize the treatment site over the right DLPFC by modifying the BeamF3 method to the contralateral side. We have previously reported good congruency between the BeamF3 heuristic method and MRI-guided neuronavigation. Prior to the first treatment, each subject's resting motor threshold (RMT) will first be determined according to published methods.
Patients will receive 3 minutes of iTBS every 30 minutes for a total of 15 session over two separate days three weeks apart day of treatment using the following parameters: 50 Hz triplet bursts, 5 bursts per second, 2 s on and 8 s off for 20 trains of 600 pulses, preceded by an introductory 3-train acclimatization titration, at an intensity of 80% of the RMT. The treatment protocol will be repeated 3 weeks after the initial treatment day.
| Study group | Role | What they receive |
|---|---|---|
| active aiTBS plus DCS | Experimental | Not described Receives: Drug: D-Cycloserine (DCS); Device: Intermittent Theta Burst Stimulation (iTBS) |
| active aiTBS plus placebo DCS | Placebo comparator | Not described Receives: Drug: Placebo; Device: Intermittent Theta Burst Stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of one-day iTBS+DCS: Enrolment
Enrollment rate: participants enrolled ÷ enrolment target by the end of 1.5 years will be ≥ 70% of the enrollment targe
Measured: 2 years
Feasibility: Adherence
Proportion of randomized participants receiving ≥80% of scheduled iTBS sessions, defined as ≥24 session
Measured: 2 years
Feasibility: dropout rates
Percentage of dropout rates attributable to the intervention will be ≤ 10%
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a two-parallel arm, randomized double-blind (patient, rater), placebo-controlled trial design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA, University of British Columbia
- Investigators
- Fidel Vila-Rodriguez, M.D., PhD, FRCPC, DFAPA, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773935
- Sponsor's protocol ID
- H25-03191
- Acronym
- ONE-P_FR
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-day rTMS + D-cycloserine to Treat PTSD in First Responders
- ClinicalTrials.gov ID
- NCT07773935
- Acronym / sponsor ID
- ONE-P_FR / H25-03191
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- Transcranial Magnetic Stimulation, iTBS, PTSD, Post Traumatic Stress Disorder, Neuroplastogen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPAUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the feasibility and tolerability of a one-day protocol of repetitive transcranial magnetic stimulation with D-cycloserine (DCS) as an augmentation strategy in first responders who have PTSD.
Detailed description
In this feasibility and tolerability trail, 50 patients with PTSD will be recruited at UBC. Patients will be randomised to receive either aiTBS plus DCS or aiTBS plus placebo DCS. The primary outcome is to evaluate the feasibility and tolerability of active aiTBS plus D-Cycloserine (DCS) versus active aiTBS plus placebo-DCS, using a one-day regimen of 15 treatment sessions, in active military personnel or veterans who suffer PTSD. A secondary aim is to explore preliminary signal of clinical efficacy of active aiTBS plus D-Cycloserine (DCS) on the primary outcome to inform sample size calculation for a definitive trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is a two-parallel arm, randomized double-blind (patient, rater), placebo-controlled trial design.
| Arm | Type | Receives |
|---|---|---|
| active aiTBS plus DCS | Experimental | Drug: D-Cycloserine (DCS), Device: Intermittent Theta Burst Stimulation (iTBS) |
| active aiTBS plus placebo DCS | Placebo comparator | Drug: Placebo, Device: Intermittent Theta Burst Stimulation (iTBS) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- are outpatients between the ages of 19-60;
- are voluntary and competent to consent;
- are first responders (active, on leave or retired);
- have DSM-5 diagnosis of PTSD with a CAPS for DSM-5 (CAPS-5) score ≥ 25;
- 17-item Hamilton Depression Rating Scale score ≤ 23;
Key exclusion criteria (16 listed)
- have a Severe Substance Use Disorder (except tobacco) within the last three (3) months;
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;
- have active suicidal intent;
- are pregnant;
- have a lifetime MINI diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms;
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 |
|---|---|---|
| D-Cycloserine (DCS)Participants randomized to the active treatment arm will receive DCS 125 mg orally, administered as one capsule around one hour before active aiTBS treatment. | Drug | active aiTBS plus DCS |
| PlaceboParticipants randomized to the placebo arm will receive one matched placebo capsule administered orally at the same time point and according to the same procedures as the active investigational product. | Drug | active aiTBS plus placebo DCS |
| Intermittent Theta Burst Stimulation (iTBS)rTMS will employ the MagPro X100/R30 stimulator (MagVenture, Farum, Denmark) equipped with the B70 coil. A scalp heuristic will be used to localize the treatment site over the right DLPFC by modifying the BeamF3 method to the contralateral side. We have previously reported good congruency between the BeamF3 heuristic method and MRI-guided neuronavigation. Prior to the first treatment, each subject's resting motor threshold (RMT) will first be determined according to published methods. Patients will receive 3 minutes of iTBS every 30 minutes for a total of 15 session over two separate days three weeks apart day of treatment using the following parameters: 50 Hz triplet bursts, 5 bursts per second, 2 s on and 8 s off for 20 trains of 600 pulses, preceded by an introductory 3-train acclimatization titration, at an intensity of 80% of the RMT. The treatment protocol will be repeated 3 weeks after the initial treatment day. | Device | active aiTBS plus DCS, active aiTBS plus placebo DCS |
Primary outcome
Feasibility of one-day iTBS+DCS: Enrolment
Time frame: 2 years
Enrollment rate: participants enrolled ÷ enrolment target by the end of 1.5 years will be ≥ 70% of the enrollment targe
Feasibility: Adherence
Time frame: 2 years
Proportion of randomized participants receiving ≥80% of scheduled iTBS sessions, defined as ≥24 session
Feasibility: dropout rates
Time frame: 2 years
Percentage of dropout rates attributable to the intervention will be ≤ 10%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Fidel Vila-Rodriguez, M.D., PhD, FRCPC, DFAPA principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-Cycloserine (DCS) and Intermittent Theta Burst Stimulation (iTBS) in people with PTSD - Post Traumatic Stress Disorder, run by Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA at 1 site in Canada.
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 16 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: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Ding, BSc ((604)-822-7308, ninet.lab@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of one-day iTBS+DCS: Enrolment (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.