Trial Outcomes & Findings for Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy (NCT NCT03889756)
NCT ID: NCT03889756
Last Updated: 2023-04-24
Results Overview
Establish if repeated ketamine will be efficacious medically and psychiatrically, as measured by a significant reduction in CDRS score in those treated with ketamine at the end of the dosing paradigm. The Children's Depression Rating Scale (CDRS) is a clinician-rated instrument with 17 items scored on a 1 to 5 or 1 to 7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. Scores of 20-30 suggest borderline depression. Scores of 40-60 indicate moderate depression.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
3 participants
Primary outcome timeframe
Day 18
Results posted on
2023-04-24
Participant Flow
Participant milestones
| Measure |
Ketamine
Ketamine is an FDA-approved anesthetic agent that is commonly used to induce surgical anesthesia due to its low incidence of significant respiratory depression and hypotension. It as a N-methyl-D-aspartate (NMDA) receptor antagonist and glutamatergic modulator, and has been demonstrated in multiple controlled clinical trials to have rapidly acting antidepressant and anti-suicidal effects in adults.
Ketamine infusion: The dose of ketamine established in prior research (0.5 mg/kg over 40 minutes) will be used in this study to minimize risks. The maximum total single dose allowed in this study will be 40mg, corresponding to a weight of 80kg.
|
Midazolam
Midazolam, the active control in this study, is a medication that is approved by the Food and Drug Administration as a sedative for both children and adults.It is a benzodiazepine with a short half-life that was chosen so as to blind the psychotomimetic effects of Ketamine.
Midazolam infusion: The weight-based midazolam dosing established in prior ketamine trials in adults (0.045mg/kg) will be used to minimize risks, as this is considered a very low dose compared to the sedation literature. The maximum total dose allowed in this study will be 3.6mg per infusion, corresponding to a weight of 80kg.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy
Baseline characteristics by cohort
| Measure |
Overall Participants
n=3 Participants
Participants enrolled in the trial. Due to the small sample size, data will be presented together to avoid unblinding.
|
|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 18Population: all those enrolled in the study prior to termination
Establish if repeated ketamine will be efficacious medically and psychiatrically, as measured by a significant reduction in CDRS score in those treated with ketamine at the end of the dosing paradigm. The Children's Depression Rating Scale (CDRS) is a clinician-rated instrument with 17 items scored on a 1 to 5 or 1 to 7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. Scores of 20-30 suggest borderline depression. Scores of 40-60 indicate moderate depression.
Outcome measures
| Measure |
Ketamine
n=1 Participants
Ketamine is an FDA-approved anesthetic agent that is commonly used to induce surgical anesthesia due to its low incidence of significant respiratory depression and hypotension. It as a N-methyl-D-aspartate (NMDA) receptor antagonist and glutamatergic modulator, and has been demonstrated in multiple controlled clinical trials to have rapidly acting antidepressant and anti-suicidal effects in adults.
Ketamine infusion: The dose of ketamine established in prior research (0.5 mg/kg over 40 minutes) will be used in this study to minimize risks. The maximum total single dose allowed in this study will be 40mg, corresponding to a weight of 80kg.
|
Midazolam
n=2 Participants
Midazolam, the active control in this study, is a medication that is approved by the Food and Drug Administration as a sedative for both children and adults.It is a benzodiazepine with a short half-life that was chosen so as to blind the psychotomimetic effects of Ketamine.
Midazolam infusion: The weight-based midazolam dosing established in prior ketamine trials in adults (0.045mg/kg) will be used to minimize risks, as this is considered a very low dose compared to the sedation literature. The maximum total dose allowed in this study will be 3.6mg per infusion, corresponding to a weight of 80kg.
|
|---|---|---|
|
Efficacy of a Multiple-dosing Ketamine Infusion Paradigm (2 Infusions Per Week for 3 Weeks) Compared to Midazolam in Adolescents With Treatment Resistant Depression Using the Children's Depression Rating Scale (CDRS)
|
42 score on a scale
Interval 42.0 to 42.0
|
62 score on a scale
Interval 62.0 to 62.0
|
PRIMARY outcome
Timeframe: Day 18Establish if repeated ketamine will be tolerated as measured by drop-out counts.
Outcome measures
| Measure |
Ketamine
n=1 Participants
Ketamine is an FDA-approved anesthetic agent that is commonly used to induce surgical anesthesia due to its low incidence of significant respiratory depression and hypotension. It as a N-methyl-D-aspartate (NMDA) receptor antagonist and glutamatergic modulator, and has been demonstrated in multiple controlled clinical trials to have rapidly acting antidepressant and anti-suicidal effects in adults.
Ketamine infusion: The dose of ketamine established in prior research (0.5 mg/kg over 40 minutes) will be used in this study to minimize risks. The maximum total single dose allowed in this study will be 40mg, corresponding to a weight of 80kg.
|
Midazolam
n=2 Participants
Midazolam, the active control in this study, is a medication that is approved by the Food and Drug Administration as a sedative for both children and adults.It is a benzodiazepine with a short half-life that was chosen so as to blind the psychotomimetic effects of Ketamine.
Midazolam infusion: The weight-based midazolam dosing established in prior ketamine trials in adults (0.045mg/kg) will be used to minimize risks, as this is considered a very low dose compared to the sedation literature. The maximum total dose allowed in this study will be 3.6mg per infusion, corresponding to a weight of 80kg.
|
|---|---|---|
|
Tolerability of a Multiple-dosing Ketamine Infusion Paradigm (2 Infusions Per Week for 3 Weeks) Compared to Midazolam in Adolescents With Treatment Resistant Depression
|
0 Participants
|
0 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: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine
n=1 participants at risk
Ketamine is an FDA-approved anesthetic agent that is commonly used to induce surgical anesthesia due to its low incidence of significant respiratory depression and hypotension. It as a N-methyl-D-aspartate (NMDA) receptor antagonist and glutamatergic modulator, and has been demonstrated in multiple controlled clinical trials to have rapidly acting antidepressant and anti-suicidal effects in adults.
Ketamine infusion: The dose of ketamine established in prior research (0.5 mg/kg over 40 minutes) will be used in this study to minimize risks. The maximum total single dose allowed in this study will be 40mg, corresponding to a weight of 80kg.
|
Midazolam
n=2 participants at risk
Midazolam, the active control in this study, is a medication that is approved by the Food and Drug Administration as a sedative for both children and adults.It is a benzodiazepine with a short half-life that was chosen so as to blind the psychotomimetic effects of Ketamine.
Midazolam infusion: The weight-based midazolam dosing established in prior ketamine trials in adults (0.045mg/kg) will be used to minimize risks, as this is considered a very low dose compared to the sedation literature. The maximum total dose allowed in this study will be 3.6mg per infusion, corresponding to a weight of 80kg.
|
|---|---|---|
|
Eye disorders
Diplopia
|
100.0%
1/1 • Up to 6 months
|
100.0%
2/2 • Up to 6 months
|
|
Nervous system disorders
Numbness
|
100.0%
1/1 • Up to 6 months
|
100.0%
2/2 • Up to 6 months
|
|
Eye disorders
Blurred Vision
|
100.0%
1/1 • Up to 6 months
|
100.0%
2/2 • Up to 6 months
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Up to 6 months
|
100.0%
2/2 • Up to 6 months
|
|
Cardiac disorders
Tachycardia
|
100.0%
1/1 • Up to 6 months
|
50.0%
1/2 • Up to 6 months
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Up to 6 months
|
100.0%
2/2 • Up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
100.0%
1/1 • Up to 6 months
|
50.0%
1/2 • Up to 6 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Up to 6 months
|
100.0%
2/2 • Up to 6 months
|
|
Cardiac disorders
Palpitations
|
100.0%
1/1 • Up to 6 months
|
0.00%
0/2 • Up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Up to 6 months
|
50.0%
1/2 • Up to 6 months
|
|
Ear and labyrinth disorders
Hearing Changes
|
100.0%
1/1 • Up to 6 months
|
0.00%
0/2 • Up to 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus at Infusion Site
|
100.0%
1/1 • Up to 6 months
|
0.00%
0/2 • Up to 6 months
|
|
Nervous system disorders
Tics
|
100.0%
1/1 • Up to 6 months
|
0.00%
0/2 • Up to 6 months
|
|
Nervous system disorders
Lightheadedness
|
100.0%
1/1 • Up to 6 months
|
0.00%
0/2 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
100.0%
1/1 • Up to 6 months
|
0.00%
0/2 • Up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Stress Fracture
|
100.0%
1/1 • Up to 6 months
|
0.00%
0/2 • Up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place