Clinical TrialTreatment-Resistant Depression (TRD)KetamineCompleted

Ketamine Infusions for PTSD and Treatment-Resistant Depression

The purpose of this study is to see whether ketamine, when given as repeated infusions, can produce quick and sustained improvement in depression and PTSD symptoms for individuals who have not had their symptoms effectively treated by current treatments.

Target Enrollment
20 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Pilot, single-group treatment study of six IV ketamine infusions (0.5 mg/kg) administered Monday–Wednesday–Friday over 2 weeks to veterans with treatment-resistant depression and chronic PTSD (n=20).

Participants remain on-site for approximately 3 hours on infusion days; outcomes include depressive and PTSD symptom severity, safety, and durability of response with follow-up visits over 2 months after the infusion period.

Study Protocol

Preparation

sessions

Dosing

6 sessions
180 min each

Integration

sessions

Study Arms & Interventions

Six ketamine infusions

experimental

Six IV infusions of ketamine 0.5 mg/kg over 2 weeks (Mon/Wed/Fri).

Interventions

  • Ketamine0.5 mg/kg
    via IV• six infusions over 2 weeks• 6 doses total

    Infusions on Mon/Wed/Fri; 3 h observation post-infusion.

Participants

Ages
18 – 75
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Male or female veterans aged 18 to 75 years.
  • Participants must have a telephone in their home and ability to hear telephone conversations.
  • Participants must meet current DSM-IV criteria for major depressive disorder (MDD), single or recurrent, without psychotic features
  • Participants must meet DSM-5 criteria for current post-traumatic stress disorder (PTSD) and have received a diagnosis of PTSD greater than or equal to 3 months prior to assessment.
  • Current major depressive episode resistant to treatment.
  • If applicable, current antidepressant dosages including augmenting agents and/or frequency and duration of psychotherapy sessions must remain stable for at least 6 weeks prior to beginning of the study.

Exclusion Criteria

  • Exclusion Criteria:
  • Inability to speak English
  • 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.
  • Current or lifetime diagnosis of a Cluster B disorder.
  • History of moderate or severe traumatic brain injury, Parkinson's disease, dementia of any type, multiple sclerosis, seizures or other CNS related disorders.
  • History of comorbid substance disorder within 6 months of screening as assessed using the Mini International Neuropsychiatric Interview (MINI), plus positive urine toxicology screen test during baseline assessments.
  • Prior use of ketamine as an antidepressant.
  • Clinically unstable medical illness that could compromise the patient's ability to tolerate or likely interfere with the study procedures (e.g., history of or current myocardial ischemia or arrhythmias, congestive heart failure, severe pulmonary, renal, or hepatic disease, uncontrolled hypertension)
  • Current or within less than 14 days use of barbiturates or monoamine oxidase inhibitors (MAOI).
  • History of antidepressant- or substance-induced hypomania.
  • History of first degree relative(s) with an Axis I psychotic disorder.
  • 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 with intent and/or plan.

Study Details

Locations

Minneapolis Va Health Care System, Minneapolis MN — Minneapolis, Minnesota, United States

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