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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine infusion | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 0.3 mg/kg/hr of ketamine infused for 100 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, last acute phase observation (approximately 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, last acute phase observation (approximately 2 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William V Bobo, MD | Consultant - Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27656788 | Result | 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. |
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Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between 12/30/14 and 5/18/16.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | units on a scale | baseline, last acute phase observation (approximately 2 weeks) |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinical worsening - behavioral outburst and suicide threats | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dissociation | Psychiatric disorders | Systematic Assessment |
Lack of placebo or other control group and small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William V. Bobo, M.D. | Mayo Clinic | 507-538-9041 | Bobo.William@mayo.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D016728 | Self-Injurious Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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.) | 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.) | 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). | 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). | baseline, last acute phase observation (approximately 2 weeks) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Remission was defined as a MADRS total score of less than or equal to 9 measured 24 hours after any acute phase infusion.
| OG002 | Non-Remission | Subjects who did not have a MADRS total score less than or equal to 9 measured 24 h after any acute phase infusion |
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| 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. | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | percentage change in score | baseline, last acute phase observation (approximately 2 weeks) |
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| 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. | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | units on a scale | baseline, last acute phase observation (approximately 2 weeks) |
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| 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. | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | percentage change in score | baseline, last acute phase observation |
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| 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. | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | units on a scale | baseline, last acute phase observation (approximately 2 weeks) |
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| 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. | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | percentage change in score | baseline, last acute phase observation (approximately 2 weeks) |
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| 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. | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | units on a scale | baseline, last acute phase observation (approximately 2 weeks) |
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| 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. | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | percentage change in score | baseline, last acute phase observation (approximately 2 weeks) |
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| 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. | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion | Posted | Mean | Standard Deviation | units on a scale | baseline, last acute phase observation (approximately 2 weeks) |
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| 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. | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | percentage change in score | baseline, last acute phase observation (approximately 2 weeks) |
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| 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.) | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | units on a scale | baseline, last acute phase observation (approximately 2 weeks) |
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| 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.) | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | percentage change in score | baseline, last acute phase observation (approximately 2 weeks) |
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| 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). | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | units on a scale | baseline, last acute phase observation (approximately 2 weeks) |
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| 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). | Statistical analyses included all subjects who received at least one acute-phase ketamine infusion. | Posted | Mean | Standard Deviation | percentage change in score | baseline, last acute phase observation (approximately 2 weeks) |
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| 1 |
| 12 |
| 2 |
| 12 |
| 12 |
| 12 |
| Suicide | Psychiatric disorders | Systematic Assessment | Subject died by suicide 10 weeks after being withdrawn from the study. |
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| Dizziness | General disorders | Systematic Assessment |
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| Numbness or tingling in extremities | General disorders | Systematic Assessment |
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| Sleepiness or sedation | General disorders | Systematic Assessment |
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| tearfulness/emotionality | Psychiatric disorders | Systematic Assessment |
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| Facial numbness | Nervous system disorders | Systematic Assessment |
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| Transient increases in systolic blood pressure | Blood and lymphatic system disorders | Systematic Assessment |
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| Transient increases in diastolic blood pressue | Blood and lymphatic system disorders | Systematic Assessment |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
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| Superiority |
| alpha level of 0.05. | t-test, 2 sided | <0.08 | Superiority |
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| Superiority |
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| Superiority |
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| Superiority |
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| Superiority |
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| Superiority |