Status:
COMPLETED
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Minneapolis Veterans Affairs Medical Center
Conditions:
Post-Traumatic Stress Disorders
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 disabil...
Detailed Description
This study is designed to better characterize the neurocognitive and associated functional connectivity mechanisms underlying comorbid post-traumatic stress disorder (PTSD) and major depressive disord...
Eligibility Criteria
Inclusion
- For the PTSD+MDD group, inclusion criteria are:
- 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
- For the Healthy Controls group, inclusion criteria are:
- Female/Male veterans
- 18 to 75 years old
- Does not meet DSM-5 criteria for MDD, single or recurrent, moderate-severe without psychotic features
- Does not meet DSM-5 criteria for chronic PTSD or subthreshold PTSD
- Not on medications for managing a psychiatric indication
- Sixth grade reading level
- Ability to provide consent
- For the Depression-only group, inclusion criteria are:
- Female/Male veterans
- 18 to 75 years old
- Experienced a traumatic event that meets DSM-5 criterion A for a diagnosis of PTSD but does not meet sufficient criteria (B-E) necessary for a diagnosis of PTSD or subthreshold PTSD
- Meets criteria for MDD, single or recurrent, moderate-severe
- If applicable, 6 weeks of stable antidepressants/augmenting agents
- Sixth grade reading level
- Ability to provide consent
- For the PTSD-only group, inclusion criteria are:
- Female/Male veterans
- 18 to 75 years old
- Meets DSM-5 criteria for chronic PTSD or subthreshold PTSD \[meets criterion A (traumatic event), criterion B (intrusion symptoms), and 2 of the following 3 criteria: C (avoidance symptoms), D (negative alterations in cognitions and mood), or E (marked alterations in arousal and reactivity)\]
- Does not meet DSM-5 criteria for MDD, single or recurrent, moderate-severe without psychotic features
- If applicable, 6 weeks of stable antidepressants/augmenting agents
- Sixth grade reading level
- Ability to provide consent
Exclusion
- For the PTSD+MDD group, exclusion criteria are:
- Inability or unwillingness to provide written informed consent
- Moderate/severe cognitive impairment
- 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
- Imminent risk of suicidal/homicidal ideation and/or behavior
- Inability to undergo MRI (i.e. claustrophobia, ferromagnetic implants, etc.)
- For the Healthy Controls group, exclusion criteria are:
- Inability or unwillingness to provide written informed consent
- Moderate/severe cognitive impairment
- History of any major medical or psychiatric disorders
- 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
- Imminent risk of suicidal/homicidal ideation and/or behavior
- Inability to undergo MRI (i.e. claustrophobia, ferromagnetic implants, etc.)
- For the Depression-only group, exclusion criteria are:
- Inability or unwillingness to provide written informed consent
- Moderate/severe cognitive impairment
- Meet DSM-5 criteria for PTSD or subthreshold PTSD
- 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
- Imminent risk of suicidal/homicidal ideation and/or behavior
- Inability to undergo MRI (i.e. claustrophobia, ferromagnetic implants, etc.)
- For the PTSD-only group, exclusion criteria are:
- Inability or unwillingness to provide written informed consent
- Moderate/severe cognitive impairment
- Meet DSM-5 criteria for a diagnosis of MDD, single or recurrent, moderate to severe
- 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
- Imminent risk of suicidal/homicidal ideation and/or behavior
- Inability to undergo MRI (i.e. claustrophobia, ferromagnetic implants, etc.)
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2024
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04032301
Start Date
September 30 2019
End Date
November 10 2024
Last Update
June 27 2025
Active Locations (1)
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1
Minneapolis Veterans Affairs Health Care System
Minneapolis, Minnesota, United States, 55417