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

NCT04352621 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-04-20

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2022-05-01
Completion
2022-05-01
FDA Drug
Yes

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Entities

Diseases

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 NCT04352621 on ClinicalTrials.gov