ClinicalTrials.gg
Not yet recruitingNCT07777380ONE-PUpdated Aug 20, 2026

ONE-P TMS Military Veterans

A Phase 2 interventional study of D-Cycloserine (DCS) and Placebo in PTSD - Post Traumatic Stress Disorder, sponsored by Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA. Not yet recruiting at 1 site in Canada. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
All
01

Study 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 military personnel and veterans 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.

02

Conditions studied

  • PTSD - Post Traumatic Stress Disorder

Keywords

  • Transcranial Magnetic Stimulation
  • iTBS
  • PTSD
  • Post Traumatic Stress Disorder
  • Neuroplastogen
03

In context

Combat Disorders

200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.

This study's planned enrollment of 50 is below the median of 72 across 167 interventional studies indexed under Combat Disorders.

Browse Combat Disorders studies →

Lead sponsor

Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • are outpatients between the ages of 19-60;
  • are voluntary and competent to consent;
  • are military personnel or veterans;
  • have 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;
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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;
  • 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 (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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    active aiTBS plus DCS

    Drug: D-Cycloserine (DCS) · Device: Intermittent Theta Burst Stimulation (iTBS)

  • Placebo comparator
    active aiTBS plus placebo DCS

    Drug: Placebo · Device: Intermittent Theta Burst Stimulation (iTBS)

Interventions

  • Participants randomized to the active treatment arm will receive DCS 125 mg orally, administered as one capsule around one hour before active aiTBS treatment.

  • DrugPlacebo

    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.

  • DeviceIntermittent 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.

06

What researchers measure

Primary outcomes

  1. 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 target.

    Time frame: 1.5 years

  2. Feasibility: Adherence

    Proportion of randomized participants receiving ≥80% of scheduled iTBS sessions, defined as ≥24 sessions

    Time frame: 1.5 years

  3. Feasibility: dropout rates

    Percentage of dropout rates attributable to the intervention will be ≤ 10%

    Time frame: 1.5 years

Other outcomes

  1. Treatment group differences in change from baseline to 3-weeks post-first one-day treatment on the Clinician-Administered Posttraumatic Stress Disorder Scale for DSM 5 (CAPS-5) Total Severity Score

    Exploratory efficacy outcome: change in Clinician-Administered PTSD Scale for DSM 5 (CAPS-5). Total Severity Score (20 item sum, range 0-80, higher score=greater severity) in change from baseline to 3-weeks after the intervention. Weathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, \& Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013.

    Time frame: 3 weeks

  2. Treatment group differences in change from baseline to 6-weeks post-first one-day treatment on the Clinician-Administered Posttraumatic Stress Disorder Scale for DSM 5 (CAPS-5) Total Severity Score

    Exploratory efficacy outcome: change in Clinician-Administered PTSD Scale for DSM 5 (CAPS-5). Total Severity Score (20-item sum, range 0-80, higher score=greater severity) in change from baseline to 6-weeks after the intervention. Weathers, FW, Blake, DD, Schnurr, PP, Kaloupek, DG, Marx, BP, \& Keane, TM. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). www.ptsd.va.gov: National Center for PTSD, 2013. Time Frame: 6 weeks

    Time frame: 6 weeks

07

Study locations

1 site
  • Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
    Vancouver, British Columbia V6T 2A1, Canada
    • Amanda Ding · Contactninet.lab@ubc.ca · (604)-822-7308
    • Fidel Vila-Rodriguez · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07777380
Lead sponsor
Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA
Responsible party
Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA (Principle Investigator, University of British Columbia) — Sponsor-investigator
First posted
Aug 20, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Aug 20, 2026

Study contacts

Amanda Ding, BSc
Contact
ninet.lab@ubc.ca
(604)-822-7308
Fidel Vila-Rodriguez, M.D., PhD, FRCPC, DFAPA
principal investigator · University of British Columbia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cycloserine

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