Intranasal Ketamine for Suicidal Ideation in Veterans
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03788694|
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Suicidal Ideation||Drug: Ketamine||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Open Label, Intranasal Ketamine for Suicidal Ideation in Veterans|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Intranasal Ketamine
Subjects will receive study medication, intranasal ketamine.
8 doses of intranasal ketamine; 40 mg per dose.
- Change in Beck Scale for Suicidal Ideation (BSSI) [ Time Frame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks ]Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks ]The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
- The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) [ Time Frame: Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks ]QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al. 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788694
|Contact: Rachel Harris, MA||718-584-9000 ext 3718||Rachel.Harris6@va.gov|
|Contact: Marianne Goodman, MD||718-584-9000 ext 5188||Marianne.Goodman@va.gov|
|United States, New York|
|James J. Peters VA Medical Center||Recruiting|
|Bronx, New York, United States, 10468|
|Contact: Rachel Harris, MA 718-584-9000 ext 3718 Rachel.Harris6@va.gov|
|Contact: Rene Kahn, MD 718-584-9000 ext 5225 firstname.lastname@example.org|
|Principal Investigator: Marianne Goodman, MD|