Trial Outcomes & Findings for Ketamine for Older Adults Pilot (NCT NCT04504175)

NCT ID: NCT04504175

Last Updated: 2023-02-14

Results Overview

Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 25 participants
• Primary outcome timeframe: 4 weeks for acute phase, 8 weeks for continuation phase
• Results posted on: 2023-02-14

Participant Flow

Participant milestones

Measure	Acute Acute phase: ketamine infusions twice a week for 4 weeks Ketamine: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes
Acute Phase STARTED	25
Acute Phase COMPLETED	23
Acute Phase NOT COMPLETED	2
Continuation Phase STARTED	15
Continuation Phase COMPLETED	15
Continuation Phase NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine for Older Adults Pilot

Baseline characteristics by cohort

Measure	Acute Infusion n=23 Participants Acute phase: ketamine infusions twice a week for 4 weeks Ketamine: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes
Age, Continuous	71.5 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 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	23 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
CIRS-G Total	8.1 units on a scale STANDARD_DEVIATION 5.4 • n=5 Participants
MADRS Total	24.4 units on a scale STANDARD_DEVIATION 7.9 • n=5 Participants
Years of education	16.2 years STANDARD_DEVIATION 1.9 • n=5 Participants
DCCS	98.2 Z-score STANDARD_DEVIATION 13.9 • n=5 Participants
Flanker	82.7 Z-score STANDARD_DEVIATION 9.0 • n=5 Participants
List Sorting	101.0 Z-score STANDARD_DEVIATION 15.6 • n=5 Participants
Picture Sequence Memory	102.5 Z-score STANDARD_DEVIATION 13.2 • n=5 Participants
Pattern Processing Speed	87.7 units on a scale STANDARD_DEVIATION 17.7 • n=5 Participants
Fluid Cognition Composite	92.4 t-score STANDARD_DEVIATION 13.7 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks for acute phase, 8 weeks for continuation phase

Population: 25 adults ages 60 years or over with Treatment-Resistant Depression (TRD) received IV ketamine infusion twice a week for 4 weeks (the "acute phase"); people who responded to the infusion at the end of the acute phase went to receive weekly infusions for 4 more weeks in a "continuation phase."

Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.

Outcome measures

Measure	Acute Infusion n=25 Participants Acute phase: ketamine infusions twice a week for 4 weeks Ketamine: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes
Remission From Depression Acute phase	6 Participants
Remission From Depression Continuation phase	4 Participants

Adverse Events

Acute

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Continuation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acute n=23 participants at risk Acute phase: ketamine infusions twice a week for 4 weeks Ketamine: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes	Continuation n=15 participants at risk Continuation phase: those who completed the acute phase and continued for an additional 4 weeks to total 8 weeks Ketamine: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes
General disorders Headache	4.3% 1/23 • Number of events 1 • 4-8 weeks: The first period (Acute Phase) lasted 4 weeks, those who went to the Continuation Phase continued for an additional 4 weeks to total 8 weeks As far as adverse events (AE's) for this pilot study, all events were recorded during the Acute Phase. No AE's were reported in the Continuation Phase.	0.00% 0/15 • 4-8 weeks: The first period (Acute Phase) lasted 4 weeks, those who went to the Continuation Phase continued for an additional 4 weeks to total 8 weeks As far as adverse events (AE's) for this pilot study, all events were recorded during the Acute Phase. No AE's were reported in the Continuation Phase.
General disorders Nausea with vomitting	4.3% 1/23 • Number of events 1 • 4-8 weeks: The first period (Acute Phase) lasted 4 weeks, those who went to the Continuation Phase continued for an additional 4 weeks to total 8 weeks As far as adverse events (AE's) for this pilot study, all events were recorded during the Acute Phase. No AE's were reported in the Continuation Phase.	0.00% 0/15 • 4-8 weeks: The first period (Acute Phase) lasted 4 weeks, those who went to the Continuation Phase continued for an additional 4 weeks to total 8 weeks As far as adverse events (AE's) for this pilot study, all events were recorded during the Acute Phase. No AE's were reported in the Continuation Phase.
Respiratory, thoracic and mediastinal disorders Upper respitory symptoms	4.3% 1/23 • Number of events 1 • 4-8 weeks: The first period (Acute Phase) lasted 4 weeks, those who went to the Continuation Phase continued for an additional 4 weeks to total 8 weeks As far as adverse events (AE's) for this pilot study, all events were recorded during the Acute Phase. No AE's were reported in the Continuation Phase.	0.00% 0/15 • 4-8 weeks: The first period (Acute Phase) lasted 4 weeks, those who went to the Continuation Phase continued for an additional 4 weeks to total 8 weeks As far as adverse events (AE's) for this pilot study, all events were recorded during the Acute Phase. No AE's were reported in the Continuation Phase.
General disorders Swelling in feet and ankles	4.3% 1/23 • Number of events 1 • 4-8 weeks: The first period (Acute Phase) lasted 4 weeks, those who went to the Continuation Phase continued for an additional 4 weeks to total 8 weeks As far as adverse events (AE's) for this pilot study, all events were recorded during the Acute Phase. No AE's were reported in the Continuation Phase.	0.00% 0/15 • 4-8 weeks: The first period (Acute Phase) lasted 4 weeks, those who went to the Continuation Phase continued for an additional 4 weeks to total 8 weeks As far as adverse events (AE's) for this pilot study, all events were recorded during the Acute Phase. No AE's were reported in the Continuation Phase.

Additional Information

Dr. Eric Lenze

Washington University in St. Louis

Phone: 314-362-5154

Email: lenzee@wustl.edu

Results disclosure agreements

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