CompletedNCT02094898KetamineUpdated Aug 11, 2017Results posted

Ketamine for Depression and Suicide Risk

A Phase 2 interventional study of Ketamine in Depression and Suicide, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-11.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 12
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study summary

The purpose of this research study was to find out if the medication known as ketamine could help the symptoms of depression. This drug is approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent; however, it is not approved for use in depression treatment. The FDA allowed the use of this drug in this research study.

Read the detailed description

This was a single-arm, open-label trial conducted in two phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission (Montgomery Åsberg Depression Rating Scale (MÅDRS)) total score less than or equal to 9 measured 24h after any acute-phase infusion) received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.Those who responded to i.v. ketamine (less than or equal to 50% reduction from baseline in MÅDRS total score) but did not remit during acute-phase were not eligible for continuation-phase treatment. Suicidal ideation was assessed clinically throughout the trial, supplemented by scores on the MÅDRS suicide item.

Conditions studied

Depression
Suicide

Browse trials for

Keywords

Depression
Unipolar
Bipolar
Suicidal

In context

Depression

8,059 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 12 is below the median of 84 across 6,722 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Current psychiatric hospital inpatient at Mayo Clinic at time of initiation of treatment.
Ability to provide informed consent
Male/Female
Age 18-65 yrs.
Major Depressive Disorder or Bipolar Disorder I or Bipolar Disorder II with Patient Health Questionnaire-9 (PHQ 9) score ≥15 at hospital assessment
Treatment resistant depression (TRD) as defined by at least two previous antidepressant or mood stabilizing treatments for depression in adequate dose for 8 weeks
Patient reported overall suicide risk score ≥3 on the Suicide Status Form (SSF II-R) or score of ≥1on Item 9 of PHQ-9 (all at admission assessment)
Ability to pass comprehension assessment test related to effects of ketamine and trial objectives and criteria
Voluntary admission

Exclusion criteria

Exclusion Criteria:

Diagnosis of schizophrenia, schizoaffective disorder, or active psychosis
Index episode of depression greater than 2 years
Ongoing prescription of ≥4 mg lorazepam equivalents total daily or a.m. dosing of any benzodiazepine at time of assessment
Currently undergoing electroconvulsive therapy, deep brain stimulation or transcranial magnetic stimulation as acute series or for maintenance
Any active or unstable medical condition as judged by principal investigator
Previous use or abuse of methamphetamine, cocaine, stimulants (prescribed and illicit) within past 12 months
Any current abuse or dependence of alcohol or drugs (except nicotine) and abuse or dependence of drugs and alcohol only in full remission (> 1 month, \< 12 months). Patients will be allowed to enroll if their drug and alcohol abuse / dependence is in full (complete, not partial) sustained (> 1 year) remission.
History of traumatic brain injury
Developmental delay and intellectual disorder
Encephalopathy (clinical diagnosis within prior 12 months of delirium)
Cognitive disorder (mild and major)
Previous participation in earlier Ketamine trial
Pregnancy
Prisoners
Involuntarily hospitalized

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

Experimental
Ketamine infusion
This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.
Drug: Ketamine

Interventions

DrugKetamine
0.3 mg/kg/hr of ketamine infused for 100 minutes
Also known as: Ketalar

What researchers measure

Primary outcomes

MADRS Total Score at Baseline and Last Acute Phase Observation
The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.
Time frame: baseline, last acute phase observation (approximately 2 weeks)

Secondary outcomes

MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation
The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 1 Score at Baseline and Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Time frame: baseline, last acute phase observation
MADRS Factor 2 Score at Baseline and Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (Negative Thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (negative thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 3 Score at Baseline and Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (Detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 4 Score at Baseline and Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (Neurovegetative Symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (neurovegetative symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)
Time frame: baseline, last acute phase observation (approximately 2 weeks)
MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation
The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)
Time frame: baseline, last acute phase observation (approximately 2 weeks)
Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation
The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).
Time frame: baseline, last acute phase observation (approximately 2 weeks)
CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation
The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).
Time frame: baseline, last acute phase observation (approximately 2 weeks)

Results

Posted Aug 11, 2017

Limitations and caveats

Lack of placebo or other control group and small sample size.

Participant flow

Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between 12/30/14 and 5/18/16.

Participant flow — Overall Study
Milestone	Ketamine Infusion
Started	12
Completed	7
Not completed	5
Withdrew: Clinical worsening	2
Withdrew: Adverse event	2
Withdrew: Lack of efficacy	1

Outcome measures

PrimaryMADRS Total Score at Baseline and Last Acute Phase Observation

The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · units on a scale

MADRS Total Score at Baseline and Last Acute Phase Observation
units on a scale	Entire Cohort	Remission	Non-Remission
Baseline	29.4 ± 7.5	29.4 ± 8.2	29.4 ± 7.7
Last acute phase observation	15.9 ± 10.6	5.4 ± 3.4	23.4 ± 6.3

Statistical analysis

Entire Cohort · t-test, 2 sided · p = <0.01
Remission · t-test, 2 sided · p = <0.05

SecondaryMADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · percentage change in score

MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation
percentage change in score	Entire Cohort	Remission	Non-Remission
MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation	-41.5 ± 40.3	-79.1 ± 13.0	-14.5 ± 11.0

Statistical analysis

Remission · t-test, 2 sided · p = <0.001

SecondaryMADRS Factor 1 Score at Baseline and Last Acute Phase Observation

The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · units on a scale

MADRS Factor 1 Score at Baseline and Last Acute Phase Observation
units on a scale	Entire Cohort	Remission	Non-Remission
Baseline	7.4 ± 2.0	7.4 ± 2.6	7.4 ± 1.7
Last acute phase observation	3.5 ± 2.3	1.2 ± 0.5	5.1 ± 0.5

Statistical analysis

Entire Cohort · t-test, 2 sided · p = <0.01
Remission · t-test, 2 sided · p = <0.01
Non-Remission · t-test, 2 sided · p = <0.08

SecondaryMADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation

Time frame:: baseline, last acute phase observation
Reported as:: Mean · percentage change in score

MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation
percentage change in score	Entire Cohort	Remission	Non-Remission
MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation	-50.3 ± 35.7	-83.6 ± 15.7	-26.5 ± 24.2

Statistical analysis

Remission · t-test, 2 sided · p = <0.001

SecondaryMADRS Factor 2 Score at Baseline and Last Acute Phase Observation

The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (Negative Thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · units on a scale

MADRS Factor 2 Score at Baseline and Last Acute Phase Observation
units on a scale	Entire Cohort	Remission	Non-Remission
Baseline	6.0 ± 1.5	6.2 ± 1.6	5.9 ± 1.6
Last acute phase observation	3.4 ± 1.7	1.8 ± 1.5	4.6 ± 0.5

Statistical analysis

Entire Cohort · t-test, 2 sided · p = <0.01
Remission · t-test, 2 sided · p = <0.08

SecondaryMADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation

The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (negative thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · percentage change in score

MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation
percentage change in score	Entire Cohort	Remission	Non-Remission
MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation	-37.0 ± 36.5	-65.4 ± 31.4	-16.7 ± 25.2

Statistical analysis

Remission · t-test, 2 sided · p = <0.01

SecondaryMADRS Factor 3 Score at Baseline and Last Acute Phase Observation

The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (Detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · units on a scale

MADRS Factor 3 Score at Baseline and Last Acute Phase Observation
units on a scale	Entire Cohort	Remission	Non-Remission
Baseline	9.5 ± 3.1	9.8 ± 2.7	9.3 ± 3.5
Last acute phase observation	4.9 ± 3.5	1.4 ± 1.3	7.4 ± 1.8

Statistical analysis

Entire Cohort · t-test, 2 sided · p = <0.01
Remission · t-test, 2 sided · p = <0.01

SecondaryMADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation

The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · percentage change in score

MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation
percentage change in score	Entire Cohort	Remission	Non-Remission
MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation	-40.2 ± 48.5	-84.3 ± 14.8	-8.9 ± 37.3

Statistical analysis

Remission · t-test, 2 sided · p = <0.01

SecondaryMADRS Factor 4 Score at Baseline and Last Acute Phase Observation

The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (Neurovegetative Symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · units on a scale

MADRS Factor 4 Score at Baseline and Last Acute Phase Observation
units on a scale	Entire Cohort	Remission	Non-Remission
Baseline	6.5 ± 3.0	6.0 ± 3.8	6.9 ± 2.6
Last acute phase observation	3.8 ± 3.6	1.0 ± 1.2	5.9 ± 3.4

Statistical analysis

Entire Cohort · t-test, 2 sided · p = <0.08
Remission · t-test, 2 sided · p = <0.08

SecondaryMADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation

The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (neurovegetative symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · percentage change in score

MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation
percentage change in score	Entire Cohort	Remission	Non-Remission
MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation	-36.0 ± 58.0	-84.3 ± 20.4	-8.4 ± 54.4

Statistical analysis

Remission · t-test, 2 sided · p = <0.001

SecondaryMADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation

The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · units on a scale

MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation
units on a scale	Entire Cohort	Remission	Non-Remission
Baseline	2.9 ± 1.1	3.2 ± 1.1	2.7 ± 1.1
Last acute phase observation	1.7 ± 0.8	1.2 ± 0.8	2.2 ± 0.4

Statistical analysis

Entire Cohort · t-test, 2 sided · p = <0.05
Remission · t-test, 2 sided · p = <0.08

SecondaryMADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · percentage change in score

MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation
percentage change in score	Entire Cohort	Remission	Non-Remission
MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation	-26.7 ± 45.4	-50.0 ± 46.8	-7.2 ± 37.1

Statistical analysis

Remission · t-test, 2 sided · p = <0.001

SecondaryClinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation

The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · units on a scale

Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation
units on a scale	Entire Cohort	Remission	Non-Remission
Baseline	5.6 ± 0.5	5.4 ± 0.5	5.7 ± 0.5
Last acute phase observation	3.9 ± 1.7	2.6 ± 0.9	4.9 ± 1.6

Statistical analysis

Entire Cohort · t-test, 2 sided · p = <0.01
Remission · t-test, 2 sided · p = <0.01

SecondaryCGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation

Time frame:: baseline, last acute phase observation (approximately 2 weeks)
Reported as:: Mean · percentage change in score

CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation
percentage change in score	Entire Cohort	Remission	Non-Remission
CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation	-29.4 ± 30.8	-50.7 ± 20.3	-14.3 ± 28.7

Adverse events

Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ketamine Infusion	1/12 (8.3%)	2/12 (16.7%)	12/12 (100%)

Most frequent serious events

Most frequent serious events
Event	Ketamine Infusion
Clinical worsening - behavioral outburst and suicide threatsPsychiatric disorders	1/12
SuicidePsychiatric disorders	1/12

Most frequent other events

Most frequent other events
Event	Ketamine Infusion
Transient increases in systolic blood pressureBlood and lymphatic system disorders	12/12
Transient increases in diastolic blood pressueBlood and lymphatic system disorders	12/12
DissociationPsychiatric disorders	9/12
DizzinessGeneral disorders	7/12
Numbness or tingling in extremitiesGeneral disorders	7/12
Sleepiness or sedationGeneral disorders	6/12
tearfulness/emotionalityPsychiatric disorders	4/12
Facial numbnessNervous system disorders	3/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Ketamine Infusion
Mean	45.8 ± 8

Sex: Female, Male
Sex: Female, Male(Participants)	Ketamine Infusion
Female	11
Male	1

Region of Enrollment
Region of Enrollment(participants)	Ketamine Infusion
United States	12

Study locations

1 site

Mayo Clinic
Rochester, Minnesota 55905, United States

References and documents

Publications

Vande Voort JL, Morgan RJ, Kung S, Rasmussen KG, Rico J, Palmer BA, Schak KM, Tye SJ, Ritter MJ, Frye MA, Bobo WV. Continuation phase intravenous ketamine in adults with treatment-resistant depression. J Affect Disord. 2016 Dec;206:300-304. doi: 10.1016/j.jad.2016.09.008. Epub 2016 Sep 12. Erratum In: J Affect Disord. 2018 Aug 15;236:313. doi: 10.1016/j.jad.2017.09.024. PubMed 27656788 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02094898
Lead sponsor: Mayo Clinic
Responsible party: William V. Bobo, M.D. (Consultant - Psychiatry, Mayo Clinic) — Principal investigator
First posted: Mar 24, 2014
Start date: Sep 2014
Primary completion: Jul 2016
Completion: Aug 2016
Results posted: Aug 11, 2017
Last update: Aug 11, 2017

Study contacts

William V Bobo, MD

principal investigator · Consultant - Psychiatry

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Ketamine for Depression and Suicide Risk

Study summary

Conditions studied

Browse trials for

Keywords

In context

Depression

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

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Inclusion criteria

Exclusion criteria