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NCT04032301CompletedPhase 1

Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans

Characterization of Comorbid Post-traumatic Stress Disorder and Major Depressive Disorder Utilizing Ketamine as an Experimental Medicine Probe

Source: ClinicalTrials.gov · Last updated 27 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
67 (actual)
First submitted
26 Jun 2019
Start date
30 Sept 2019
Primary completion date
16 Sept 2024
Lead sponsor
University of Minnesota
Diseases
Depression
NCT number
NCT04032301

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 67
  • From 30 Sept 2019 to the primary completion date, 16 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior use of ketamine as an antidepressant
  • Inability to undergo MRI (i.e. claustrophobia, ferromagnetic implants, etc.)
    • For the Healthy Controls group, exclusion criteria are:
  • Prior use of ketamine as an antidepressant
  • Inability to undergo MRI (i.e. claustrophobia, ferromagnetic implants, etc.)
    • For the Depression-only group, exclusion criteria are:
  • Prior use of ketamine as an antidepressant
  • Inability to undergo MRI (i.e. claustrophobia, ferromagnetic implants, etc.)
    • For the PTSD-only group, exclusion criteria are:
  • Prior use of ketamine as an antidepressant
  • Inability to undergo MRI (i.e. claustrophobia, ferromagnetic implants, etc.)

Other illness

  • 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
  • Clinically unstable medical illness
  • 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
  • Clinically unstable medical illness
  • 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
  • Clinically unstable medical illness
  • 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
  • Clinically unstable medical illness

Other

  • For the PTSD+MDD group, exclusion criteria are:
  • Inability or unwillingness to provide written informed consent
  • 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 or unwillingness to provide written informed consent
  • 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 or unwillingness to provide written informed consent
  • Meet DSM-5 criteria for PTSD or subthreshold PTSD
  • 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 or unwillingness to provide written informed consent
  • Meet DSM-5 criteria for a diagnosis of MDD, single or recurrent, moderate to severe
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Minneapolis Veterans Affairs Health Care System
Coordinator of this site? Confirm its status		MinneapolisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.