Trial Outcomes & Findings for Ketamine for Relapse Prevention in Recurrent Depressive Disorder (NCT NCT02661061)
NCT ID: NCT02661061
Last Updated: 2020-01-13
Results Overview
The outcomes for this pilot trial are process outcomes, primarily rates of recruitment and retention. Thus, the completion rate for the randomised treatment phase is the primary outcome. The study is not designed to assess efficacy.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
2 years
Results posted on
2020-01-13
Participant Flow
Participants were inpatients at St Patrick's Mental Health Services admitted for treatment of an acute depressive episode with a previous history of depression
Participants were randomised from n=28 participants in an observational phase, all of whom were receiving inpatient treatment for recurrent depressive disorder. Participants were monitored weekly for response to treatment and those who responded were invited to be randomised.
Participant milestones
| Measure |
Ketamine
Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.
Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.
|
Midazolam
Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.
Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Ketamine
Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.
Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.
|
Midazolam
Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.
Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Ketamine for Relapse Prevention in Recurrent Depressive Disorder
Baseline characteristics by cohort
| Measure |
Ketamine
n=5 Participants
Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.
Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.
|
Midazolam
n=4 Participants
Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.
Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All randomised participants who received one infusion were analysed (intention to treat)
The outcomes for this pilot trial are process outcomes, primarily rates of recruitment and retention. Thus, the completion rate for the randomised treatment phase is the primary outcome. The study is not designed to assess efficacy.
Outcome measures
| Measure |
Ketamine
n=5 Participants
Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.
Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.
|
Midazolam
n=4 Participants
Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.
Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.
|
|---|---|---|
|
Completion Rate for Randomised Treatment Phase
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 8 monthsClinical outcomes are secondary in this pilot trial. The 24-item Hamilton Rating Scale for Depression (HRSD-24) was 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 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, and deliberate self-harm/suicide also constitute relapse. Relapse may also occur during the eight-week treatment phase and is captured here.
Outcome measures
| Measure |
Ketamine
n=5 Participants
Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.
Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.
|
Midazolam
n=4 Participants
Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.
Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.
|
|---|---|---|
|
Depression Relapse Rate During Treatment and Follow-up Phase
|
2 Participants
|
3 Participants
|
Adverse Events
Ketamine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Midazolam
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine
n=5 participants at risk
Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.
Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.
|
Midazolam
n=4 participants at risk
Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.
Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.
|
|---|---|---|
|
Immune system disorders
Delayed hypersensitivity reaction
|
20.0%
1/5 • Number of events 1 • Adverse event information was collected over the entire study time frame, 29 months, from December 2015 to May 2018. Individual participants were assessed over an approximately seven-month period including their inpatient admission, eight-week randomised treatment phase, and 26-week follow-up period.
Tolerability of the trial agents was assessed at multiple points before, during and after treatment sessions using a battery of assessments used in assessing for physical and psychotomimetic side effects of ketamine (CADSS, BPRS, PRISE and YMRS), standard in the field of ketamine clinical trials for depression, as well as assessment of physical health parameters before, during and after assessments.
|
0.00%
0/4 • Adverse event information was collected over the entire study time frame, 29 months, from December 2015 to May 2018. Individual participants were assessed over an approximately seven-month period including their inpatient admission, eight-week randomised treatment phase, and 26-week follow-up period.
Tolerability of the trial agents was assessed at multiple points before, during and after treatment sessions using a battery of assessments used in assessing for physical and psychotomimetic side effects of ketamine (CADSS, BPRS, PRISE and YMRS), standard in the field of ketamine clinical trials for depression, as well as assessment of physical health parameters before, during and after assessments.
|
|
Immune system disorders
Urticaria
|
0.00%
0/5 • Adverse event information was collected over the entire study time frame, 29 months, from December 2015 to May 2018. Individual participants were assessed over an approximately seven-month period including their inpatient admission, eight-week randomised treatment phase, and 26-week follow-up period.
Tolerability of the trial agents was assessed at multiple points before, during and after treatment sessions using a battery of assessments used in assessing for physical and psychotomimetic side effects of ketamine (CADSS, BPRS, PRISE and YMRS), standard in the field of ketamine clinical trials for depression, as well as assessment of physical health parameters before, during and after assessments.
|
25.0%
1/4 • Number of events 1 • Adverse event information was collected over the entire study time frame, 29 months, from December 2015 to May 2018. Individual participants were assessed over an approximately seven-month period including their inpatient admission, eight-week randomised treatment phase, and 26-week follow-up period.
Tolerability of the trial agents was assessed at multiple points before, during and after treatment sessions using a battery of assessments used in assessing for physical and psychotomimetic side effects of ketamine (CADSS, BPRS, PRISE and YMRS), standard in the field of ketamine clinical trials for depression, as well as assessment of physical health parameters before, during and after assessments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place