Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
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|ClinicalTrials.gov Identifier: NCT04032301|
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : October 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorders Major Depressive Disorder||Drug: Ketamine Other: Normal Saline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Experimental versus Placebo|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Characterization of Comorbid Post-traumatic Stress Disorder and Major Depressive Disorder Utilizing Ketamine as an Experimental Medicine Probe|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||September 1, 2024|
|Estimated Study Completion Date :||September 1, 2024|
Experimental: Intravenous ketamine infusions
Six infusions of 0.5 mg/kg ketamine hydrochloride solution over 3 weeks.
Six infusions of intravenous 0.5 mg/kg ketamine hydrochloride solution over 3 weeks.
Other Name: Ketamine Hydrochloride
Placebo Comparator: Intravenous saline infusions
Six infusions of normal saline solution over 3 weeks.
Other: Normal Saline
Six infusions of intravenous normal saline solution over 3 weeks.
Other Name: Sodium Chloride in Water
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: At baseline, 60 minutes pre-infusion, 24 hours post-infusion, and after infusion series up to 2 months. ]Change in major depressive disorder symptoms over the course of the intervention.
- PTSD Symptom Scale-Interview for DSM-5 (PSS-I-5) [ Time Frame: At baseline, 60 minutes pre-infusion, 24 hours post-infusion, and after infusion series up to 2 months. ]Change in post-traumatic stress disorder symptoms over the course of the intervention.
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): NCT04032301
|Contact: Sey Lee, BS||612-629-7489||Sey.Lee@va.gov|
|Contact: Christina S Albott, MD, MA||612-273-9041||Cristina.Albott@va.gov|
|United States, Minnesota|
|Minneapolis Veterans Affairs Health Care System||Recruiting|
|Minneapolis, Minnesota, United States, 55417|
|Contact: Sey Lee, BS|
|Principal Investigator: Christina S Albott, MD, MA|
|Principal Investigator:||Christina S Albott, MD, MA||Minneapolis Veterans Affairs Medical Center|