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D-Cycloserine for Depression

Phase 1
Waitlist Available
Led By Alexander McGirr, MD PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8)
Awards & highlights

Study Summary

This trial tests whether giving a weight-based dose of an old antibiotic (D-cycloserine) with a non-invasive brain stimulation treatment (iTBS) improves depression more than a fixed dose in people with Major Depressive Disorder.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine whether blood serum levels of D-cycloserine achieved by weight-based dosing is consistent across time.
Individual differences in D-cycloserine serum concentration will be correlated with clinical outcomes
Individual fidelity to the protocol will be correlated with differential change in
+2 more
Secondary outcome measures
Change in Cognitive Function - THINC-integrated tool (THINC-it)- Choice Reaction Time
Change in Cognitive Function - THINC-integrated tool (THINC-it)- Digit Symbol Substitution
Change in Cognitive Function - THINC-integrated tool (THINC-it)- Perceived Deficits Questionnaire - 5 item scale (PDQ-5)
+11 more
Other outcome measures
Incidence of Treatment-Emergent Adverse Events
Safety hypothesis: There will be no clinically significant changes in QTc
Safety hypothesis: There will be no clinically significant changes in bloodwork; ALT
+14 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: D-CycloserineExperimental Treatment2 Interventions
Prior to initiating TMS therapy, participants will orally ingest a capsule containing 100mg of the antibiotic d-cycloserine. During TMS therapy, participants will orally ingest a capsule containing a weight-based dose of the antibiotic d-cycloserine (dosed 25mg/17.5kg body weight) daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D-cycloserine
2013
Completed Phase 4
~1060
Transcranial Magnetic Stimulator
2019
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,142 Total Patients Enrolled
31 Trials studying Depression
10,628 Patients Enrolled for Depression
Alexander McGirr, MD PhDPrincipal InvestigatorUniversity of Calgary
4 Previous Clinical Trials
110 Total Patients Enrolled
3 Trials studying Depression
110 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research accept individuals aged 80 or older?

"The parameters of this trial necessitate that participants are aged between 18 to 65. On the other hand, there are 191 clinical trials for those below 18 years old and 979 studies catering to individuals above the age of 65."

Answered by AI

Has the U.S. Food and Drug Administration granted its seal of approval to D-Cycloserine?

"Data on the safety and efficacy of D-Cycloserine is scant, prompting our team to rate its security at a 1. This rating denotes that this trial is only in Phase 1."

Answered by AI

What is the cap on participant numbers for this investigation?

"Affirmative. The clinicaltrial.gov page for this research indicates that it is currently recruiting participants, having been first posted on October 12th 2022 and most recently updated on February 16th 2023. There are 12 patients being sought after across one site of enrollment."

Answered by AI

Is it currently feasible to apply for participation in this clinical trial?

"Affirmative. Per the information posted on clinicaltrials.gov, this medical study is actively accepting participants as of now. It was launched on October 12th 2022 and its parameters were most recently edited February 16th 2023; it aims to enroll a total of 12 patients from one site."

Answered by AI

Which individuals are eligible to be part of this clinical investigation?

"This clinical trial is enrolling 12 volunteers aged 18 to 65 who have been diagnosed with Major Depressive Disorder as per the DSM-5 criteria. Eligibility requirements include: males and females between 18-65 years of age, mentally able to consent to treatment, an adequate antidepressant medication trial within the current episode that was unsuccessful or not tolerated well; a score ≥18 on the HAMD-17 item; no change in psychotropic medications for four weeks prior to randomization; adherance to the treatment schedule; TASS questionnaire completion (TMS adult safety screening); reference range results from blood work (CBC, electrolytes, B"

Answered by AI

What are the projected outcomes of this particular clinical investigation?

"The primary outcome of this clinical trial, assessed over a designated period, will be the correlation between individual differences in D-cycloserine serum concentration and associated results. Secondary outcomes include determining the number of participants that demonstrate 50% or greater improvement in depression (as measured by MADRS), changes in self-reported anxiety levels (as gauged with GAD-7 questionnaire) and alterations to depressive symptomatology (evaluated through QIDS-SR)."

Answered by AI
~5 spots leftby Apr 2025