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This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode in Major Depressive Disorder (MDD) or Bipolar Disorder (BD) with or without comorbid recent abuse of alcohol.
Clinicians have a limited ability to predict imminent suicidal behavior and efficacious treatments are not available to treat suicidal patients. Thus, Rapid-acting treatments for suicidal individuals are truly needed. This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode (in Major Depressive Disorder, MDD or Bipolar Disorder, BD) with or without comorbid recent abuse of alcohol. These results will elucidate the antisuicidal effects of ketamine using the intranasal route along with the identification of associated mediators or moderators; this approach has the potential for enormous public health impact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal ketamine | Experimental | Intranasal ketamine |
|
| Placebo | Placebo Comparator | non-active placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal ketamine | Drug | Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg). |
| Measure | Description | Time Frame |
|---|---|---|
| Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI) | The scale contains 19 items rated on a scale from 0 to 2, allowing score range from 0 to 38, score over 4 (first five items) will be considered inclusion criteria. Higher values indicate worsening or presence of suicidal ideation. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) | It has ten items, each item yields a score of 0 to 6. Hence the overall score ranges from 0 to 60. Higher scores indicate more severe depression. | 24 hours |
| Snaith-Hamilton Pleasure Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Machado-Vieira, MD, PhD, MSc | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38696221 | Derived | Jones GH, Vecera CM, Ruiz AC, Wu HE, McInturff SI, Orejarena MJ, Smith KA, Soares JC, Zarate CA, Lane SD, Machado-Vieira R. A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of the Acute Antisuicidal and Antidepressant Effects of Intranasal (R,S)-Ketamine in Severe Unipolar and Bipolar Depression With and Without Comorbid Alcohol Use Disorder. J Clin Psychiatry. 2024 Apr 24;85(2):23m14974. doi: 10.4088/JCP.23m14974. |
| Label | URL |
|---|---|
| Department of Psychiatry, Dr Rodrigo Machado-Vieira | View source |
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5 participants who were enrolled were not randomized and did not start the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Ketamine | Intranasal ketamine Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg). |
| FG001 | Placebo | non-active placebo Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Ketamine | Intranasal ketamine Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg). |
| 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 | Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI) | The scale contains 19 items rated on a scale from 0 to 2, allowing score range from 0 to 38, score over 4 (first five items) will be considered inclusion criteria. Higher values indicate worsening or presence of suicidal ideation. | Data for this outcome measure were not collected for 1 participant in the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
48 hours
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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 | Intranasal Ketamine | Intranasal ketamine Intranasal ketamine: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cognitive side effect | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rodrigo Machado-Vieira, MD, PhD, MSc | The University of Texas Health Science Center at Houston | (713) 741-5000 | Rodrigo.MachadoVieira@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2019 | Jan 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| D003863 | Depression |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Randomized, Double-Blind, Placebo-Controlled
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|
| Placebo | Drug | Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. |
|
The Snaith-Hamilton Pleasure Scale (SHAPS) is an assessment of anhedonia, which is the inability to experience pleasure. The SHAPS has 14 items. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. A response of "strongly disagree" or "disagree" equals one point, and a response of "strongly agree" or "agree" equals 0 points. Thus, the final score ranges from 0 to 14. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. |
| 24 hours |
| Alcohol Urge Questionnaire (AUQ) | Alcohol Urge Questionnaire (AUQ) is a multi-item measure of self-reported urges to drink alcohol, predictor of drinking abuse and relapse. AUQ is an 8-item questionnaire. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. Total score ranges from 8 to 56, and a higher score reflects greater craving. | 24 hours |
| Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS) | The YMRS has 11 items, and total score ranges from 0 to 88, with a higher score indicating greater mania. | 24 hours |
| Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS) | The CADSS consists of 23 items, and each item is rated on a scale from 0 (not at all) to 4 (severe), with the total score ranging from 0 to 92. A higher score indicates greater severity of dissociative state. | 24 hours |
| Experimental Therapeutics and Molecular Pathophysiology, UTHealth, Houston, Texas | View source |
| BG001 | Placebo | non-active placebo Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo | non-active placebo Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. |
|
|
| Secondary | Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) | It has ten items, each item yields a score of 0 to 6. Hence the overall score ranges from 0 to 60. Higher scores indicate more severe depression. | Data for this outcome measure were not collected for 1 participant in the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
|
|
| Secondary | Snaith-Hamilton Pleasure Scale | The Snaith-Hamilton Pleasure Scale (SHAPS) is an assessment of anhedonia, which is the inability to experience pleasure. The SHAPS has 14 items. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. A response of "strongly disagree" or "disagree" equals one point, and a response of "strongly agree" or "agree" equals 0 points. Thus, the final score ranges from 0 to 14. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. | Data for this outcome measure were not collected for 1 participant in the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
|
|
| Secondary | Alcohol Urge Questionnaire (AUQ) | Alcohol Urge Questionnaire (AUQ) is a multi-item measure of self-reported urges to drink alcohol, predictor of drinking abuse and relapse. AUQ is an 8-item questionnaire. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. Total score ranges from 8 to 56, and a higher score reflects greater craving. | Data for this outcome measure were not collected for 1 participant in the ketamine arm and one participant in the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
|
|
| Secondary | Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS) | The YMRS has 11 items, and total score ranges from 0 to 88, with a higher score indicating greater mania. | Data for this outcome measure were not collected for 1 participant in the placebo arm | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
|
|
| Secondary | Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS) | The CADSS consists of 23 items, and each item is rated on a scale from 0 (not at all) to 4 (severe), with the total score ranging from 0 to 92. A higher score indicates greater severity of dissociative state. | Data for this outcome measure were not collected for 1 participant in the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 12 |
| 17 |
| EG001 | Placebo | non-active placebo Placebo: Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. | 0 | 11 | 0 | 11 | 4 | 11 |
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| D019973 |
| Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |