Trial Outcomes & Findings for The UTHealth Ketamine Project (NCT NCT02882711)

NCT ID: NCT02882711

Last Updated: 2020-11-24

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline through week 12
• Results posted on: 2020-11-24

Participant Flow

Four participants who were enrolled met exclusion criteria and therefore did not start the study.

Participant milestones

Measure	Ketamine 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).
Overall Study STARTED	6
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The UTHealth Ketamine Project

Baseline characteristics by cohort

Measure	Ketamine n=6 Participants 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through week 12

Population: This data was only collected for the 2 participants who completed the study.

Outcome measures

Measure	Ketamine n=2 Participants 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).
Safety Will be Measured Through Number of Adverse Events	2 adverse events

SECONDARY outcome

Timeframe: Baseline, week 8, week 12

Population: Clinical Global Impressions (CGI) scale data was not collected for any participant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, week 8, week 12

Population: PHQ-9 data was collected at baseline for all 6 participants who started the study. PHQ-9 data was not collected at week 8 or week 12 for 4 participants, per study protocol.

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.

Outcome measures

Measure	Ketamine n=6 Participants 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).
Severity of Depressive Symptoms as Assessed by the PHQ-9 Baseline	12.67 units on a scale Standard Deviation 9.501
Severity of Depressive Symptoms as Assessed by the PHQ-9 Week 8	5 units on a scale Standard Deviation 5.657
Severity of Depressive Symptoms as Assessed by the PHQ-9 Week 12	5 units on a scale Standard Deviation 5.657

Adverse Events

Ketamine

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ketamine n=6 participants at risk 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).
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • 12 weeks

Other adverse events

Measure	Ketamine n=6 participants at risk 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).
Psychiatric disorders dissociation	16.7% 1/6 • Number of events 1 • 12 weeks

Additional Information

Salih Selek, M.D.

The University of Texas Health Science Center at Houston

Phone: 713-741-3936

Email: salih.selek@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place