NCT05731323

D-Cycloserine+iTBS PK Study

Completed Phase 1 Last updated 11 September 2023

What this trial tests

Phase 1 trial testing D-cycloserine in Major Depressive Disorder in 12 participants. Completed in 22 June 2023.

Timeline

12 October 2022

Primary endpoint
22 June 2023

22 June 2023

Quick facts

Lead sponsor	University of Calgary
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	12 October 2022
Primary completion	22 June 2023
Estimated completion	22 June 2023
Sites	1 location across Canada

Drugs / interventions tested

• D-cycloserine — full drug profile →
• Transcranial Magnetic Stimulator

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

University of Calgary

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background \& Rationale: Major Depressive Disorder (MDD) is a common and debilitating illness that that commonly does not respond to conventional treatments. Transcranial magnetic stimulation (TMS) and intermittent theta-burst stimulation (iTBS) are non-invasive neurostimulation treatments for depression that are Health Canada approved. These work by generating magnetic fields outside of the body to change the activity of brain cells to change how the brain works. They have a very favorable profile, with many patients experiencing improvement with minimal side effects.

The investigators recently completed a study pairing iTBS with an FDA approved medication that was chosen because it might enhance iTBS improvements. This medication is called D-cycloserine, an old antibiotic that is rarely used in modern times. Years after it stopped being useful as an antibiotic, scientists recognized other properties that the molecule has, and it is some of these that make it interesting to pair with iTBS. When the investigators did so, they found that compared to iTBS with a placebo, participants who received iTBS+D-cycloserine were more likely to benefit from treatment.

In this original study, all participants received a fixed dose of 100mg daily. This means that people of very different sizes could have had different drug levels, and the investigators do not know how that impacted outcomes. With this study, there will be no placebo condition because the purpose is to understand whether dosing according to weight matters.

Research Question and Objectives: To describe the pharmacokinetic profile of 100mg oral D-cycloserine and weight-based oral D-cycloserine dosed 25mg/17.5kg among individuals with depression undergoing non-invasive intermittent theta-burst stimulation to the left dorsolateral prefrontal cortex (DLPFC) in Major Depressive Disorder.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intermittent theta-burst stimulation with adjunctive D-cycloserine rapidly resolves suicidal ideation and decreases implicit association with death/suicide.
   Sohn MN, Cole J, Bray SL, McGirr A. · · 2025 · cited 4× · PMID 39905763 · DOI 10.1017/s0033291724003313