NCT04352621

Study to Assess the Effects of Intranasal Ketamine Along With rTMS for Patients With Treatment-resistant Major Depressive Disorder (TRD)

Ketamine Enhancement of rTMS for Refractory Depression

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

An open label study to assess the safety, tolerability, and effects of intranasal Ketamine in combination with rTMS for patients with treatment-resistant major depressive disorder (TRD). Patients will be given a dose of ketamine followed by 6 weeks of rTMS treatment.

Detailed description

Investigate the effects of pretreatment using a single, sub-anesthetic dose of intranasal ketamine on the response to a standard course of rTMS in patients who meet the definition of TRD.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	intranasal ketamine	Ketamine 0.5 mg/kg will be administered intranasally using an atomization device with a maximum dose of 40 mg followed by 6 weeks of rTMS treatment. .
DEVICE	rTMS treatment	patients will begin the open label trial of rTMS per the FDA-approved method on day 1 (the day after the Baseline Visit).

Timeline

• Start date: 2020-05-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2020-04-20
• Last updated: 2020-04-20

Regulatory

• FDA-regulated drug study