A Phase 3 interventional study of Intranasal ketamine and Placebo in Suicidal Ideation, Depression and Alcohol Abuse, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by The University of Texas Health Science Center, Houston · Phase 3, Interventional, and Treatment
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.
530 studies on the registry are indexed under Suicidal Ideation; 198 are open to participants now.
This study's enrollment of 33 is below the median of 80 across 440 interventional studies indexed under Suicidal Ideation.
Browse Suicidal Ideation studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intranasal ketamine
Drug: Intranasal ketamine
non-active placebo
Drug: Placebo
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).
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.
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.
Time frame: 24 hours
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.
Time frame: 24 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours
| Milestone | Intranasal Ketamine | Placebo |
|---|---|---|
| Started | 17 | 11 |
| Completed | 17 | 11 |
| Not completed | 0 | 0 |
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.
| score on a scale | Intranasal Ketamine | Placebo |
|---|---|---|
| Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI) | 10.8 ± 8.08 | 12.3 ± 7.83 |
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.
| score on a scale | Intranasal Ketamine | Placebo |
|---|---|---|
| Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) | 16.8 ± 13.7 | 22.5 ± 17.7 |
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.
| score on a scale | Intranasal Ketamine | Placebo |
|---|---|---|
| Snaith-Hamilton Pleasure Scale | 4.12 ± 4.81 | 5.00 ± 4.29 |
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.
| score on a scale | Intranasal Ketamine | Placebo |
|---|---|---|
| Alcohol Urge Questionnaire (AUQ) | 13.8 ± 12.2 | 16.3 ± 11.2 |
The YMRS has 11 items, and total score ranges from 0 to 88, with a higher score indicating greater mania.
| score on a scale | Intranasal Ketamine | Placebo |
|---|---|---|
| Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS) | 2.29 ± 2.85 | 2.40 ± 2.12 |
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.
| score on a scale | Intranasal Ketamine | Placebo |
|---|---|---|
| Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS) | 0.824 ± 2.90 | 1.60 ± 3.20 |
Collected over 48 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intranasal Ketamine | 0/17 (0%) | 0/17 (0%) | 12/17 (70.6%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 4/11 (36.4%) |
| Event | Intranasal Ketamine | Placebo |
|---|---|---|
| Cognitive side effectNervous system disorders | 12/17 | 4/11 |
| Age, Continuous(years) | Intranasal Ketamine | Placebo | Total |
|---|---|---|---|
| Mean | 39 ± 9 | 38.5 ± 13.8 | 38.8 ± 11.1 |
| Sex: Female, Male(Participants) | Intranasal Ketamine | Placebo | Total |
|---|---|---|---|
| Female | 5 | 2 | 7 |
| Male | 12 | 9 | 21 |
| Ethnicity (NIH/OMB)(Participants) | Intranasal Ketamine | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 14 | 11 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intranasal Ketamine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 11 | 8 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Region of Enrollment(Participants) | Intranasal Ketamine | Placebo | Total |
|---|---|---|---|
| United States | 17 | 11 | 28 |
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Intranasal Ketamine
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