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
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.
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.
Exclusion Criteria:
Drug: D-Cycloserine (DCS) · Device: Intermittent Theta Burst Stimulation (iTBS)
Drug: Placebo · Device: Intermittent Theta Burst Stimulation (iTBS)
Participants randomized to the active treatment arm will receive DCS 125 mg orally, administered as one capsule around one hour before active aiTBS treatment.
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.
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.
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
Feasibility: Adherence
Proportion of randomized participants receiving ≥80% of scheduled iTBS sessions, defined as ≥24 sessions
Time frame: 1.5 years
Feasibility: dropout rates
Percentage of dropout rates attributable to the intervention will be ≤ 10%
Time frame: 1.5 years
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
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
Plan to share: No
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Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA