Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans (NCT04032301) | Clinical Trial Compass
CompletedPhase 1
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
United States67 participantsStarted 2019-09-30
Plain-language summary
Co-occurring post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) is the most common response to trauma; it is associated with poor clinical outcomes and substantial human disability. Veterans with both PTSD and MDD (PTSD+MDD) have been shown to be at much greater suicidal risk than individuals with only one of these disorders. Ketamine given as repeated infusions has been shown to be effective in rapidly reducing PTSD and MDD symptoms in treatment resistant PTSD+MDD individuals. However, knowledge about the mechanisms underlying comorbid PTSD and MDD remain limited. The purpose of this study is to use repeated ketamine infusions as a probe to validate a model of PTSD+MDD that focuses on neuroanatomy and executive functioning.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Female/Male veterans
✓. 18 to 75 years old
✓. Meets DSM-5 criteria for MDD, single or recurrent, moderate-severe without psychotic features
✓. Meets DSM-5 criteria for chronic PTSD or subthreshold PTSD \[meets criterion A (traumatic event), criterion B (intrusion symptoms), and 2 of the following 3 criteria: C (avoidance symptoms), D (negative alterations in cognitions and mood), or E (marked alterations in arousal and reactivity)\]
✓. If applicable, 6 weeks of stable antidepressants/augmenting agents
✓. Sixth grade reading level
✓. Ability to provide consent
✓. Female/Male veterans
Exclusion criteria
✕. Inability or unwillingness to provide written informed consent
✕. Moderate/severe cognitive impairment
What they're measuring
1
Montgomery-Asberg Depression Rating Scale (MADRS)
Timeframe: At baseline, 60 minutes pre-infusion, 24 hours post-infusion, and after infusion series up to 2 months.
2
PTSD Symptom Scale-Interview for DSM-5 (PSS-I-5)
Timeframe: At baseline, 60 minutes pre-infusion, 24 hours post-infusion, and after infusion series up to 2 months.
✕. Current or lifetime diagnosis of psychosis-related disorder, bipolar I or II disorder, substance-induced mood disorder, or any mood disorder due to a general medical condition
✕. History of moderate or severe traumatic brain injury
✕. History of comorbid substance disorder within 1 month of screening
✕. Prior use of ketamine as an antidepressant
✕. Clinically unstable medical illness
✕. For women: pregnancy (confirmed by baseline lab test), the initiation of female hormonal treatments within 3 months of screening, or inability or unwillingness to use a medically accepted contraceptive method for the duration of the study