Ketamine for Treatment Resistant MDD

Brief Summary

This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.

Intervention / Treatment

  • Drug: Ketamine

Condition or Disease

  • Depressive Disorder, Major

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 18 Years to 65 Years   (Adult, Older Adult)
Enrollment: 20 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Sep 01, 2018
Primary Completion: Oct 01, 2020
Completion Date: Dec 30, 2020
Study First Posted: Jul 16, 2019
Results First Posted: Aug 31, 2020
Last Updated: Jul 16, 2019

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Major depression disorder (MDD) is a common psychiatric disorders with considerable impact on patients' quality of life, social and occupational function. MDD also significantly increase suicide rate. About a third of the patients with MDD suffer from moderate to severe symptoms that are fully or partially unresponsive to accepted pharmaco and / or psycho therapy. Ketamine is a widely used anesthetic. Multiple studies done over the recent years had shown its therapeutic effects in resistant depressive patients. Unlike regular antidepressants, ketamine exerts its effect within hours to few days which implies an alternative mechanism of action not fully studied. So far, there are only few reports on using repeated ketamine administration to maintain the antidepressant effect or on intra-muscular or sub-cutaneous application that can be safer and more tolerable than the intravenous route.

In the present study, the investigators aim to openly assess the safety, tolerability and effectiveness of repeated, individually tailored IM or SC ketamine for treatment resistant major depression. The investigators intend to explore questions regarding optimal dose, treatment frequency and duration. The investigators will also assess potential cognitive effects of long-term ketamine treatment and look for possible treatment outcome predictors using the Neurotrax computerized cognitive battery.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 65

This clinical trial is recruiting

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More Details

NCT Number: NCT04021433
Other IDs: 58717-HMO-CTIL
Study URL: https://ClinicalTrials.gov/show/NCT04021433
Last updated: Jun 17, 2022