Ketamine Infusions for PTSD and Treatment-Resistant Depression

May 10, 2019 updated by: Cristina Sophia Albott, Minneapolis Veterans Affairs Medical Center

Efficacy and Safety of Repeated Intravenous Subanesthetic Ketamine Infusions Among Veterans With Treatment Resistant Depression Comorbid With Chronic Post-Traumatic Stress Disorder: A Proof-of-concept Study

The relationship between depression and trauma is well established. Co-occuring depression and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower levels of functioning. Veterans with both depression and PTSD have been shown to be at much higher risk of suicide than individuals with only one of these disorders. Ketamine has been shown to have rapid antidepressant effects and also therapeutic action over PTSD symptoms. 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.

Study Overview

Detailed Description

The proposed study is a pilot study designed to determine the efficacy and safety of serial ketamine infusions among veterans with treatment-resistant depression (TRD) as well as chronic post-traumatic stress disorder (PTSD). The investigators hypothesize that six infusions of ketamine will be effective in decreasing severity of depressive symptoms and maintaining response.

Participants will be male/female veterans (18 to 75 years old) of any era or military background who suffer from TRD and chronic PTSD. Potential participants will be recruited from Mental Health clinics and screened for eligibility using a two stage process (phone/chart review, followed by interview). Participants will receive six ketamine infusions on a Monday-Wednesday-Friday schedule over 2 weeks. On the day of infusion, participants will be required to stay at the clinical site for 3 hours after the medication has been given. Follow-up visits will occur at different time points over the course of 2 months after the two week infusion period has been completed.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis Va Health Care System, Minneapolis MN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Six ketamine infusions
Six infusions of 0.5 mg/kg ketamine hydrochloride solution over 2 weeks.
Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 24 hours post-infusion
24 hours post-infusion
Clinical-Administered PTSD Scale (CAPS)
Time Frame: 2 weeks after the first infusion
2 weeks after the first infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: up to 2 months
up to 2 months
PTSD Checklist
Time Frame: 24 hours post-infusion
24 hours post-infusion
Clinical-Administered PTSD Scale (CAPS)
Time Frame: up to 2 months
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paulo Shiroma, MD, Minneapolis Veterans Affairs Medical Center
  • Principal Investigator: Cristina S Albott, MD,MA, Minneapolis Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 9, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

May 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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