NCT02882711

The UTHealth Ketamine Project

Terminated Phase 2 Results posted Last updated 24 November 2020

What this trial tests

Phase 2 trial testing Ketamine in Treatment Resistant Depression in 10 participants. Terminated before completion.

Timeline

7 November 2016

Primary endpoint
16 August 2017

16 August 2017

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	7 November 2016
Primary completion	16 August 2017
Estimated completion	16 August 2017
Sites	1 location across United States

Drugs / interventions tested

• Ketamine (ketamine) — full drug profile →

Conditions studied

• Treatment Resistant Depression — all drugs for Treatment Resistant Depression →
• Major Depressive Disorder — all drugs for Major Depressive Disorder →
• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 18 to 65, any sex, with Treatment Resistant Depression or Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety Will be Measured Through Number of Adverse Events Primary · Baseline through week 12

Group	Value	95% CI
Ketamine	2

Severity of Depressive Symptoms as Assessed by the PHQ-9 Secondary · Baseline, week 8, week 12

The Patient Health Questionnaire (PHQ)-9 is the 9-item depression module from the full Patient Health Questionnaire (PHQ) PHQ-9 total score ranges from 0 to 27 (each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day)), and a higher score indicates greater depression.

Baseline

Group	Value	95% CI
Ketamine	12.67	± 9.501

Week 8

Group	Value	95% CI
Ketamine	5	± 5.657

Week 12

Group	Value	95% CI
Ketamine	5	± 5.657

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ketamine

Serious: 1/6 (17%)

Deaths: 0/6

Serious adverse events (1 terms)

Reaction	System	Ketamine
Vomiting	Gastrointestinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Ketamine
dissociation	Psychiatric disorders	—

Most-reported serious reactions: Vomiting.

Data from ClinicalTrials.gov NCT02882711 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.