Trial Outcomes & Findings for Treatment of Suicidal Ideation With Intravenous Ketamine Infusion (NCT NCT01887990)

Results Overview

Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation. Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

2 hours

Results posted on

2017-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Suicidal, Depression With Ketamine 0.2 mg/kg IV ketamine administered as a one time dose in patients with suicidal ideatin and depression without substance use Ketamine	Suicidal, Depression With Saline comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo	Suicidal, Depression and Opioid Use With Ketamine suicidal, depressed with opioid use, given 0.2 mg/kg ketamine one time dose IV infusion	Suicidal, Depression With Opioid Use With Saline suicidal, depression with opioid use, given saline IV
Overall Study STARTED	7	7	2	2
Overall Study COMPLETED	7	7	2	2
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Suicidal, Depression With Ketamine n=7 Participants suicidal and depressed, no substance use 0.2 mg/kg IV ketamine administered as a one time dose Ketamine	Suicidal, Depression With Saline n=7 Participants suicidal and depressed, no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo	Suicidal, Depression and Opioid Use With Ketamine n=2 Participants suicidal and depressed, opioid use 0.2 mg/kg IV ketamine administered as a one time dose Ketamine	Suicidal, Depression and Opioid Use With Ketamine n=2 Participants suicidal and depressed,opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo	Total n=18 Participants Total of all reporting groups
Age, Continuous	37 years STANDARD_DEVIATION 10 • n=99 Participants	37 years STANDARD_DEVIATION 11 • n=107 Participants	31 years STANDARD_DEVIATION 1 • n=206 Participants	31 years STANDARD_DEVIATION 4 • n=7 Participants	35 years STANDARD_DEVIATION 9 • n=31 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	3 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	6 Participants n=31 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	4 Participants n=107 Participants	2 Participants n=206 Participants	2 Participants n=7 Participants	12 Participants n=31 Participants
Region of Enrollment United States	7 participants n=99 Participants	7 participants n=107 Participants	2 participants n=206 Participants	2 participants n=7 Participants	18 participants n=31 Participants

PRIMARY outcome

Timeframe: 2 hours

Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation. Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide.

Outcome measures

Outcome measures
Measure	Suicidal, Depression With Ketamine n=7 Participants 0.2 mg/kg IV ketamine administered as a one time dose Ketamine	Suicidal, Depression With Saline n=7 Participants comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo	Suicidal, Opioid Use With Ketamine n=2 Participants suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose	Suicidal, Opioid Use With Saline n=2 Participants Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
Suicidality	7.3 units on a scale Standard Deviation 11.4	21.5 units on a scale Standard Deviation 14.7	18.0 units on a scale Standard Deviation 25.5	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 2 hours

Scales and Questionnaire using the MADRS (Montgomery-Asberg Depression Rating Scale) . This is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. the scale: 0 - 6 (normal/symptom absent), 7 - 19 (mild depression), 20 - 34 (moderate depression), and \> 34 (severe depression).The overall score ranges from 0 to 60

Outcome measures

Outcome measures
Measure	Suicidal, Depression With Ketamine n=7 Participants 0.2 mg/kg IV ketamine administered as a one time dose Ketamine	Suicidal, Depression With Saline n=7 Participants comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo	Suicidal, Opioid Use With Ketamine n=2 Participants suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose	Suicidal, Opioid Use With Saline n=2 Participants Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
Depression	43.9 units on a scale Standard Deviation 26	59.4 units on a scale Standard Deviation 17.2	22.5 units on a scale Standard Deviation 17.7	12.5 units on a scale Standard Deviation 3.5

Adverse Events

Suicidal, Depression With Ketamine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Suicidal, Depression With Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Suicidal, Depression and Opioid Use With Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Suicidal, Depression and Opioid With Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Suicidal, Depression With Ketamine n=7 participants at risk Suicidal with depression and no substance use 0.2 mg/kg IV ketamine administered as a one time dose Ketamine	Suicidal, Depression With Saline n=7 participants at risk Suicidal with depression and no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo	Suicidal, Depression and Opioid Use With Ketamine n=2 participants at risk Suicidal with depression and opioid use 0.2 mg/kg IV ketamine administered as a one time dose Ketamine	Suicidal, Depression and Opioid With Saline n=2 participants at risk Suicidal with depression and opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm placebo
Nervous system disorders sedation	14.3% 1/7 • 2 weeks	0.00% 0/7 • 2 weeks	0.00% 0/2 • 2 weeks	0.00% 0/2 • 2 weeks

Additional Information

Cheryl McCullumsmith

University of Cincinnati

Phone: 513-5588022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place