Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
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|ClinicalTrials.gov Identifier: NCT04032301|
Recruitment Status : Not yet recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 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|
|Estimated Study Start Date :||September 1, 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.
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||Not yet 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|