Depression, Suicide
Conditions
Keywords
Depression, Unipolar, Bipolar, Suicidal
Brief 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.
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.
Interventions
DRUGKetamine
0.3 mg/kg/hr of ketamine infused for 100 minutes
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MADRS Total Score at Baseline and Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MADRS Factor 1 Score at Baseline and Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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. |
| MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation | baseline, 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. |
| MADRS Factor 2 Score at Baseline and Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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. |
| MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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. |
| MADRS Factor 3 Score at Baseline and Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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. |
| MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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. |
| MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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. |
| MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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. |
| MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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.) |
| MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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.) |
| Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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). |
| CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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). |
| MADRS Factor 4 Score at Baseline and Last Acute Phase Observation | baseline, last acute phase observation (approximately 2 weeks) | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between 12/30/14 and 5/18/16.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Ketamine: 0.3 mg/kg/hr of ketamine infused for 100 minutes | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Clinical Worsening | 2 |
| Overall Study | Lack of Efficacy | 1 |
Baseline characteristics
| Characteristic | Ketamine Infusion |
|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 12 |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 2 / 12 |
Outcome results
Primary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entire Cohort | MADRS Total Score at Baseline and Last Acute Phase Observation | Baseline | 29.4 units on a scale | Standard Deviation 7.5 |
| Entire Cohort | MADRS Total Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 15.9 units on a scale | Standard Deviation 10.6 |
| Remission | MADRS Total Score at Baseline and Last Acute Phase Observation | Baseline | 29.4 units on a scale | Standard Deviation 8.2 |
| Remission | MADRS Total Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 5.4 units on a scale | Standard Deviation 3.4 |
| Non-Remission | MADRS Total Score at Baseline and Last Acute Phase Observation | Baseline | 29.4 units on a scale | Standard Deviation 7.7 |
| Non-Remission | MADRS Total Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 23.4 units on a scale | Standard Deviation 6.3 |
Comparison: alpha level of 0.05.p-value: <0.01t-test, 2 sided
Comparison: alpha level of 0.05.p-value: <0.05t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entire Cohort | CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation | -29.4 percentage change in score | Standard Deviation 30.8 |
| Remission | CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation | -50.7 percentage change in score | Standard Deviation 20.3 |
| Non-Remission | CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation | -14.3 percentage change in score | Standard Deviation 28.7 |
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entire Cohort | Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation | Baseline | 5.6 units on a scale | Standard Deviation 0.5 |
| Entire Cohort | Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation | Last acute phase observation | 3.9 units on a scale | Standard Deviation 1.7 |
| Remission | Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation | Baseline | 5.4 units on a scale | Standard Deviation 0.5 |
| Remission | Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation | Last acute phase observation | 2.6 units on a scale | Standard Deviation 0.9 |
| Non-Remission | Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation | Baseline | 5.7 units on a scale | Standard Deviation 0.5 |
| Non-Remission | Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation | Last acute phase observation | 4.9 units on a scale | Standard Deviation 1.6 |
Comparison: alpha level of 0.05.p-value: <0.01t-test, 2 sided
Comparison: alpha level of 0.05.p-value: <0.01t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entire Cohort | MADRS Factor 1 Score at Baseline and Last Acute Phase Observation | Baseline | 7.4 units on a scale | Standard Deviation 2 |
| Entire Cohort | MADRS Factor 1 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 3.5 units on a scale | Standard Deviation 2.3 |
| Remission | MADRS Factor 1 Score at Baseline and Last Acute Phase Observation | Baseline | 7.4 units on a scale | Standard Deviation 2.6 |
| Remission | MADRS Factor 1 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 1.2 units on a scale | Standard Deviation 0.5 |
| Non-Remission | MADRS Factor 1 Score at Baseline and Last Acute Phase Observation | Baseline | 7.4 units on a scale | Standard Deviation 1.7 |
| Non-Remission | MADRS Factor 1 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 5.1 units on a scale | Standard Deviation 0.5 |
Comparison: alpha level of 0.05.p-value: <0.01t-test, 2 sided
Comparison: alpha level of 0.05.p-value: <0.01t-test, 2 sided
Comparison: alpha level of 0.05.p-value: <0.08t-test, 2 sided
Secondary
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
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entire Cohort | MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation | -50.3 percentage change in score | Standard Deviation 35.7 |
| Remission | MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation | -83.6 percentage change in score | Standard Deviation 15.7 |
| Non-Remission | MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation | -26.5 percentage change in score | Standard Deviation 24.2 |
Comparison: alpha level of 0.05.p-value: <0.001t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entire Cohort | MADRS Factor 2 Score at Baseline and Last Acute Phase Observation | Baseline | 6.0 units on a scale | Standard Deviation 1.5 |
| Entire Cohort | MADRS Factor 2 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 3.4 units on a scale | Standard Deviation 1.7 |
| Remission | MADRS Factor 2 Score at Baseline and Last Acute Phase Observation | Baseline | 6.2 units on a scale | Standard Deviation 1.6 |
| Remission | MADRS Factor 2 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 1.8 units on a scale | Standard Deviation 1.5 |
| Non-Remission | MADRS Factor 2 Score at Baseline and Last Acute Phase Observation | Baseline | 5.9 units on a scale | Standard Deviation 1.6 |
| Non-Remission | MADRS Factor 2 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 4.6 units on a scale | Standard Deviation 0.5 |
Comparison: alpha level of 0.05.p-value: <0.01t-test, 2 sided
Comparison: alpha level of 0.05.p-value: <0.08t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entire Cohort | MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation | -37.0 percentage change in score | Standard Deviation 36.5 |
| Remission | MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation | -65.4 percentage change in score | Standard Deviation 31.4 |
| Non-Remission | MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation | -16.7 percentage change in score | Standard Deviation 25.2 |
Comparison: alpha level of 0.05.p-value: <0.01t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entire Cohort | MADRS Factor 3 Score at Baseline and Last Acute Phase Observation | Baseline | 9.5 units on a scale | Standard Deviation 3.1 |
| Entire Cohort | MADRS Factor 3 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 4.9 units on a scale | Standard Deviation 3.5 |
| Remission | MADRS Factor 3 Score at Baseline and Last Acute Phase Observation | Baseline | 9.8 units on a scale | Standard Deviation 2.7 |
| Remission | MADRS Factor 3 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 1.4 units on a scale | Standard Deviation 1.3 |
| Non-Remission | MADRS Factor 3 Score at Baseline and Last Acute Phase Observation | Baseline | 9.3 units on a scale | Standard Deviation 3.5 |
| Non-Remission | MADRS Factor 3 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 7.4 units on a scale | Standard Deviation 1.8 |
Comparison: alpha level of 0.05.p-value: <0.01t-test, 2 sided
Comparison: alpha level of 0.05.p-value: <0.01t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entire Cohort | MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation | -40.2 percentage change in score | Standard Deviation 48.5 |
| Remission | MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation | -84.3 percentage change in score | Standard Deviation 14.8 |
| Non-Remission | MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation | -8.9 percentage change in score | Standard Deviation 37.3 |
Comparison: alpha level of 0.05.p-value: <0.01t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entire Cohort | MADRS Factor 4 Score at Baseline and Last Acute Phase Observation | Baseline | 6.5 units on a scale | Standard Deviation 3 |
| Entire Cohort | MADRS Factor 4 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 3.8 units on a scale | Standard Deviation 3.6 |
| Remission | MADRS Factor 4 Score at Baseline and Last Acute Phase Observation | Baseline | 6.0 units on a scale | Standard Deviation 3.8 |
| Remission | MADRS Factor 4 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 1.0 units on a scale | Standard Deviation 1.2 |
| Non-Remission | MADRS Factor 4 Score at Baseline and Last Acute Phase Observation | Baseline | 6.9 units on a scale | Standard Deviation 2.6 |
| Non-Remission | MADRS Factor 4 Score at Baseline and Last Acute Phase Observation | Last acute phase observation | 5.9 units on a scale | Standard Deviation 3.4 |
Comparison: alpha level of 0.05.p-value: <0.08t-test, 2 sided
Comparison: alpha level of 0.05.p-value: <0.08t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entire Cohort | MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation | -36.0 percentage change in score | Standard Deviation 58 |
| Remission | MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation | -84.3 percentage change in score | Standard Deviation 20.4 |
| Non-Remission | MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation | -8.4 percentage change in score | Standard Deviation 54.4 |
Comparison: alpha level of 0.05.p-value: <0.001t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entire Cohort | MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation | -26.7 percentage change in score | Standard Deviation 45.4 |
| Remission | MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation | -50.0 percentage change in score | Standard Deviation 46.8 |
| Non-Remission | MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation | -7.2 percentage change in score | Standard Deviation 37.1 |
Comparison: alpha level of 0.05.p-value: <0.001t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entire Cohort | MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation | Baseline | 2.9 units on a scale | Standard Deviation 1.1 |
| Entire Cohort | MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation | Last acute phase observation | 1.7 units on a scale | Standard Deviation 0.8 |
| Remission | MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation | Baseline | 3.2 units on a scale | Standard Deviation 1.1 |
| Remission | MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation | Last acute phase observation | 1.2 units on a scale | Standard Deviation 0.8 |
| Non-Remission | MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation | Baseline | 2.7 units on a scale | Standard Deviation 1.1 |
| Non-Remission | MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation | Last acute phase observation | 2.2 units on a scale | Standard Deviation 0.4 |
Comparison: alpha level of 0.05.p-value: <0.05t-test, 2 sided
Comparison: alpha level of 0.05.p-value: <0.08t-test, 2 sided
Secondary
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)
Population: Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entire Cohort | MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation | -41.5 percentage change in score | Standard Deviation 40.3 |
| Remission | MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation | -79.1 percentage change in score | Standard Deviation 13 |
| Non-Remission | MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation | -14.5 percentage change in score | Standard Deviation 11 |
Comparison: alpha level of 0.05.p-value: <0.001t-test, 2 sided