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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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