NCT02882711

The UTHealth Ketamine Project

A Naturalistic Study of Serial Infusion of Low-dose Ketamine for Treatment Resistant Depressive Disorders in an Academic Psychiatric Hospital: The UTHealth Ketamine Project

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the effectiveness of serial infusions of intravenous (IV) ketamine in adults with treatment resistant depression (TRD).

Detailed description

Thus, in the current study we want to naturalistically explore the antidepressant effects of serial slow IV infusions (40 minutes) of ketamine at a dose of 0.5 mg/kg, over a treatment period of 8 weeks in an academic psychiatric hospital. This is a minimal sedation treatment. The primary outcome measure of this study will be remission estimated based on the severity of depressive scores. After the 8 weeks of treatment, there will be a four week observational period. During the observational period, participants will receive treatment as usual and will be contacted over the phone for follow-up questions regarding their overall health status, mood and clinical state. They will also complete a neurocognitive task at the end of the 4 week observational period

Conditions

• Treatment Resistant Depression
• Major Depressive Disorder
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Ketamine	Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks and weekly for the following 4 weeks of the study treatment period (8 weeks total).

Timeline

• Start date: 2016-11-07
• Primary completion: 2017-08-16
• Completion: 2017-08-16
• First posted: 2016-08-30
• Last updated: 2020-11-24
• Results posted: 2020-11-09

Locations

1 site across 1 country: United States