Trial Outcomes & Findings for Reducing Adolescent Suicide Risk: Safety, Efficacy, and Connectome Phenotypes of Intravenous Ketamine (NCT NCT04613453)
NCT ID: NCT04613453
Last Updated: 2025-08-26
Results Overview
The C-SSRS is an assessment of suicidal ideation and behavior in clinical and research settings. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline and Day 3
Results posted on
2025-08-26
Participant Flow
Last enrolled patient skipped the blinded phase and received open-label Ketamine.
Participant milestones
| Measure |
Ketamine Infusion
Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
|
Midazolam Infusion
Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
|
|---|---|---|
|
Blinded Phase
STARTED
|
5
|
6
|
|
Blinded Phase
COMPLETED
|
5
|
6
|
|
Blinded Phase
NOT COMPLETED
|
0
|
0
|
|
Open Phase
STARTED
|
6
|
6
|
|
Open Phase
COMPLETED
|
6
|
2
|
|
Open Phase
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Adolescent Suicide Risk: Safety, Efficacy, and Connectome Phenotypes of Intravenous Ketamine
Baseline characteristics by cohort
| Measure |
Ketamine Infusion
n=5 Participants
Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
|
Midazolam Infusion
n=6 Participants
Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Non-binary
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 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
United States
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Age of depression onset
|
13 years
n=99 Participants
|
12 years
n=107 Participants
|
12.5 years
n=206 Participants
|
|
Screening Children's Depression Rating Scale-Revised (CDRS-R)
|
65.5 score on a scale
n=99 Participants
|
75 score on a scale
n=107 Participants
|
68.5 score on a scale
n=206 Participants
|
|
Screening Columbia-Suicide Severity Rating Scale (C-SSRS)
|
5 score on a scale
n=99 Participants
|
5 score on a scale
n=107 Participants
|
5 score on a scale
n=206 Participants
|
|
Number of previous antidepressant trials
|
3 trials
n=99 Participants
|
3.5 trials
n=107 Participants
|
3 trials
n=206 Participants
|
|
Number of prior suicide attempts
|
1 suicide attempts
n=99 Participants
|
1 suicide attempts
n=107 Participants
|
1 suicide attempts
n=206 Participants
|
|
Number of participants with Co-morbid anxiety disorder
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 3The C-SSRS is an assessment of suicidal ideation and behavior in clinical and research settings. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior).
Outcome measures
| Measure |
Ketamine Infusion
n=5 Participants
Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
Ketamine Infusion: Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
|
Midazolam Infusion
n=6 Participants
Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
Midazolam Infusion: Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline Suicidal Ideation
|
2.60 score on a scale
Standard Deviation 1.34
|
2.67 score on a scale
Standard Deviation 1.37
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 3 Suicidal Ideation
|
1.20 score on a scale
Standard Deviation 1.10
|
1.17 score on a scale
Standard Deviation 1.60
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline Suicidal Behavior
|
0.20 score on a scale
Standard Deviation 0.45
|
0.41 score on a scale
Standard Deviation 0.45
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 3 Suicidal Behavior
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline and Day 3Montgomery Asberg Depression Rating Scale is an 10-item scale examines depressive symptoms and will be assessed at baseline (prior to any experimental treatment), prior to each experimental treatment, and weekly during the open phase of the trial. This 10-item scale ranges from 0 to 60, with higher values representing more intensive depressive symptoms.
Outcome measures
| Measure |
Ketamine Infusion
n=5 Participants
Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
Ketamine Infusion: Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
|
Midazolam Infusion
n=6 Participants
Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
Midazolam Infusion: Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
|
|---|---|---|
|
Montgomery Asberg Depression Rating Scale
Baseline
|
30.4 score on a scale
Standard Deviation 2.07
|
33 score on a scale
Standard Deviation 11.93
|
|
Montgomery Asberg Depression Rating Scale
Day 3
|
27.2 score on a scale
Standard Deviation 4.44
|
24.17 score on a scale
Standard Deviation 17.57
|
SECONDARY outcome
Timeframe: Baseline to Day 11Children's Depression Rating Scale-Revised is a 17-item scale examines depressive symptoms in children and adolescents using the combined report of the adolescent and the parent, synthesized by a clinician. It will be administered at baseline (prior to any experimental treatment), at the end of the blinded phase of the trial (Day 11), and monthly during the open phase of the trial. This 17-item clinical scale creates scores that range from 17 to 113, with higher scores representing more intensive depressive symptoms
Outcome measures
| Measure |
Ketamine Infusion
n=5 Participants
Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
Ketamine Infusion: Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
|
Midazolam Infusion
n=6 Participants
Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
Midazolam Infusion: Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
|
|---|---|---|
|
Change in Children's Depression Rating Scale
Baseline
|
69.5 score on a scale
Interval 61.0 to 75.0
|
68 score on a scale
Interval 59.0 to 84.0
|
|
Change in Children's Depression Rating Scale
Day 11
|
54.5 score on a scale
Interval 42.0 to 71.0
|
66 score on a scale
Interval 58.0 to 73.0
|
Adverse Events
Ketamine Infusion-Blinded
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Midazolam Infusion-Blinded
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Ketamine Infusion-Unblinded
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketamine Infusion-Blinded
n=5 participants at risk
Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
|
Midazolam Infusion-Blinded
n=6 participants at risk
Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
|
Ketamine Infusion-Unblinded
n=6 participants at risk
5 of 6 participants did not respond to Midazolam and received Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes as per protocol.
|
|---|---|---|---|
|
General disorders
Emergency Department Visit
|
20.0%
1/5 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Psychiatric disorders
Self harm
|
40.0%
2/5 • 4 months
|
50.0%
3/6 • 4 months
|
0.00%
0/6 • 4 months
|
Other adverse events
| Measure |
Ketamine Infusion-Blinded
n=5 participants at risk
Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
|
Midazolam Infusion-Blinded
n=6 participants at risk
Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
|
Ketamine Infusion-Unblinded
n=6 participants at risk
5 of 6 participants did not respond to Midazolam and received Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes as per protocol.
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • 4 months
|
33.3%
2/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • 4 months
|
33.3%
2/6 • 4 months
|
66.7%
4/6 • 4 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
33.3%
2/6 • 4 months
|
|
General disorders
Fatigue
|
20.0%
1/5 • 4 months
|
50.0%
3/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
General disorders
Temperature intolerance
|
20.0%
1/5 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Infections and infestations
Eye infection
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
50.0%
3/6 • 4 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Investigations
Weight increased
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • 4 months
|
16.7%
1/6 • 4 months
|
66.7%
4/6 • 4 months
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Nervous system disorders
Sedation
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Nervous system disorders
Tension headache
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • 4 months
|
66.7%
4/6 • 4 months
|
33.3%
2/6 • 4 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
33.3%
2/6 • 4 months
|
|
Psychiatric disorders
Asthenia
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Psychiatric disorders
Confusional state
|
20.0%
1/5 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Psychiatric disorders
Illusion
|
20.0%
1/5 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Psychiatric disorders
Restlessness
|
20.0%
1/5 • 4 months
|
0.00%
0/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Psychiatric disorders
Self-destructive behaviour
|
0.00%
0/5 • 4 months
|
50.0%
3/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/5 • 4 months
|
16.7%
1/6 • 4 months
|
0.00%
0/6 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Atypical Pneumonia
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Skin and subcutaneous tissue disorders
Skin hemorrhage
|
0.00%
0/5 • 4 months
|
0.00%
0/6 • 4 months
|
16.7%
1/6 • 4 months
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/5 • 4 months
|
33.3%
2/6 • 4 months
|
16.7%
1/6 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place