Phase 2
N=12
Ketamine for Depression and Suicide Risk
Depression · Suicide
Bottom Line
View on ClinicalTrials.gov: NCT02094898 ↗Enrolled (actual)
12
Serious AEs
16.7%
Results posted
Aug 2017
Primary outcome: Primary: MADRS Total Score at Baseline and Last Acute Phase Observation — 29.4; 29.4; 29.4; 15.9 units on a scale — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ketamine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MADRS Total Score at Baseline and Last Acute Phase Observation |
29.4; 29.4; 29.4; 15.9; 5.4; 23.4 | <0.01 sig |
| SECONDARY MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation |
-41.5; -79.1; -14.5 | <0.001 sig |
| SECONDARY MADRS Factor 1 Score at Baseline and Last Acute Phase Observation |
7.4; 7.4; 7.4; 3.5; 1.2; 5.1 | <0.01 sig |
| SECONDARY MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation |
-50.3; -83.6; -26.5 | <0.001 sig |
| SECONDARY MADRS Factor 2 Score at Baseline and Last Acute Phase Observation |
6.0; 6.2; 5.9; 3.4; 1.8; 4.6 | <0.01 sig |
| SECONDARY MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation |
-37.0; -65.4; -16.7 | <0.01 sig |
| SECONDARY MADRS Factor 3 Score at Baseline and Last Acute Phase Observation |
9.5; 9.8; 9.3; 4.9; 1.4; 7.4 | <0.01 sig |
| SECONDARY MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation |
-40.2; -84.3; -8.9 | <0.01 sig |
| SECONDARY MADRS Factor 4 Score at Baseline and Last Acute Phase Observation |
6.5; 6.0; 6.9; 3.8; 1.0; 5.9 | <0.08 |
| SECONDARY MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation |
-36.0; -84.3; -8.4 | <0.001 sig |
| SECONDARY MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation |
2.9; 3.2; 2.7; 1.7; 1.2; 2.2 | <0.05 sig |
| SECONDARY MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation |
-26.7; -50.0; -7.2 | <0.001 sig |
| SECONDARY Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation |
5.6; 5.4; 5.7; 3.9; 2.6; 4.9 | <0.01 sig |
| SECONDARY CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation |
-29.4; -50.7; -14.3 | — |
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.
Eligibility Criteria
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
- 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, 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
Data sourced from ClinicalTrials.gov (NCT02094898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.