Trial Outcomes & Findings for Ketamine for Depression Relapse Prevention Following ECT (NCT NCT02414932)
NCT ID: NCT02414932
Last Updated: 2021-05-06
Results Overview
Process outcomes are primary in this pilot trial. These include recruitment methods and rate of completion and will be assessed following the completion of the trial
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
6 participants
Primary outcome timeframe
30 months
Results posted on
2021-05-06
Participant Flow
Participants who completed the entire informed consent process after treatment response to ECT are considered enrolled in this randomised pilot trial (n=6)
Participant milestones
| Measure |
Ketamine
Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate \>110/minute or systolic/diastolic blood pressure (BP) \>180/100 or \>20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.
Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland
|
Midazolam
Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.
Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Ketamine
Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate \>110/minute or systolic/diastolic blood pressure (BP) \>180/100 or \>20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.
Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland
|
Midazolam
Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.
Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Ketamine for Depression Relapse Prevention Following ECT
Baseline characteristics by cohort
| Measure |
Ketamine
n=3 Participants
Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate \>110/minute or systolic/diastolic blood pressure (BP) \>180/100 or \>20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.
Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland
|
Midazolam
n=3 Participants
Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.
Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
67 years
n=99 Participants
|
62 years
n=107 Participants
|
64 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Ireland
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Pre-ECT Hamilton Rating Scale for Depression, 24-item
|
27 units on a scale
STANDARD_DEVIATION 2.64 • n=99 Participants
|
28.3 units on a scale
STANDARD_DEVIATION 4.72 • n=107 Participants
|
27.8 units on a scale
STANDARD_DEVIATION 3.31 • n=206 Participants
|
PRIMARY outcome
Timeframe: 30 monthsProcess outcomes are primary in this pilot trial. These include recruitment methods and rate of completion and will be assessed following the completion of the trial
Outcome measures
| Measure |
Ketamine
n=3 Participants
Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate \>110/minute or systolic/diastolic blood pressure (BP) \>180/100 or \>20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.
Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland
|
Midazolam
n=3 Participants
Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.
Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd
|
|---|---|---|
|
Completion Rate for Randomised Treatment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants entered a 6-month follow up phase following randomised treatment. One participant in the ketamine arm dropped out of follow up at 12 weeks.
Clinical outcomes are secondary in this pilot trial. The 24-item Hamilton Rating Scale for Depression (HRSD-24) will be used to assess for the main clinical outcome, the relapse rate over six months. Criteria for relapse are ≥10 point increase in HRSD-24 compared to baseline Phase 2 score plus HRSD ≥16; in addition, increase in the HRSD should be maintained one week later (if indicated, additional follow-ups will be arranged). Hospital admission, further ECT, and deliberate self-harm/suicide also constitute relapse.
Outcome measures
| Measure |
Ketamine
n=3 Participants
Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate \>110/minute or systolic/diastolic blood pressure (BP) \>180/100 or \>20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.
Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland
|
Midazolam
n=3 Participants
Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.
Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd
|
|---|---|---|
|
Depression Relapse Rate
|
1 Participants
|
1 Participants
|
Adverse Events
Ketamine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Midazolam
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 |
Ketamine
n=3 participants at risk
Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate \>110/minute or systolic/diastolic blood pressure (BP) \>180/100 or \>20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.
Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland
|
Midazolam
n=3 participants at risk
Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.
Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd
|
|---|---|---|
|
Psychiatric disorders
Dissociation
|
66.7%
2/3 • Number of events 2 • 8 months (8 week treatment period and 6-month follow-up assessment period)
Tolerability of the trial agents was assessed at multiple points before, during and after treatment sessions over the 8 week treatment period using a battery of assessments(CADSS, BPRS, PRISE and YMRS) as well as assessment of physical health parameters before, during and after assessments. In addition, follow up assessments were performed at set intervals over the six-month follow-up period.
|
0.00%
0/3 • 8 months (8 week treatment period and 6-month follow-up assessment period)
Tolerability of the trial agents was assessed at multiple points before, during and after treatment sessions over the 8 week treatment period using a battery of assessments(CADSS, BPRS, PRISE and YMRS) as well as assessment of physical health parameters before, during and after assessments. In addition, follow up assessments were performed at set intervals over the six-month follow-up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place