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Adjunctive D-Cycloserine in Major Depressive Disorder

NCT03937596 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-01-10

No results posted yet for this study

Summary

Transcranial magnetic stimulation (rTMS) is an approved treatment for depression. The purpose of this study is to test an adjunctive medication, D-cycloserine, in rTMS for depression using a placebo-controlled design. D-Cycloserine is a partial N-Methyl-D-Aspartate receptor (NMDAr) agonist, and therefore may enhance the effects of rTMS, however there is data to support and refute this hypothesis. Using a double-blind design, the investigators will randomize patients with Major Depressive Disorder to receive either daily low dose D-cycloserine or placebo in conjunction with rTMS to the left dorsolateral prefrontal cortex. After 10 treatments (2 weeks), this double-blind period will conclude and all participants will receive an additional 10 treatments (2 weeks) of rTMS without any adjuncts. The primary outcome will be improvement in clinician rated depressive symptoms at the conclusion of the study.

Conditions

Interventions

DRUG

D-cycloserine

Daily oral D-cycloserine 100mg during the blinded phase (10 days).

DEVICE

Transcranial Magnetic Stimulator

Repetitive Transcranial magnetic stimulation (rTMS) will be delivered using a MagPro X100 device with B70 coil and the intermittent theta burst (iTBS) protocol to the left dorsolateral prefrontal cortex. Participants will receive daily treatments (Monday-Friday) over four weeks.

DRUG

Placebo oral capsule

Daily oral placebo during the blinded phase (10 days).

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Alexander McGirr, MD PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-12-24
Completion
2020-12-24
FDA Drug
Yes
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03937596 on ClinicalTrials.gov