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D-Cycloserine+iTBS PK Study

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

No Placebo-Only Group

Summary

This trial tests a treatment for depression using brain stimulation combined with a medication. It focuses on adults with depression who haven't improved with standard treatments. The study aims to see if adjusting the medication dose based on weight improves outcomes. The medication has been studied for a long time for various anxiety disorders, with mixed results.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Transcranial Magnetic Stimulator

2019

Completed Phase 2

~70

D-cycloserine

2013

Completed Phase 4

~1060