Ketamine-enhanced Prolonged Exposure Therapy in PTSD

Ketamine

Brief Summary

The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo to reduce symptoms of Posttraumatic Stress Disorder (PTSD) among Veteran receiving Prolonged Exposure Therapy.

Intervention / Treatment

Subjects will be randomly assigned to one of two parallel treatment conditions: 1) adjunctive ketamine infusions to prolonged exposure therapy or 2) adjunctive midazolam (active placebo) infusions to prolonged exposure therapy.
  • Ketamine (DRUG)
    FDA approved anesthetic medication with rapid acting antidepressant effects.
  • Midazolam (DRUG)
    FDA approved sedative medication with dissociative effects.

Condition or Disease

  • PTSD

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years to 75 Years
    Enrollment: 100 (ESTIMATED)
    Funded by: U.S. Fed
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    The investigators will use a sequentially numbered, opaque, sealed envelopes, pharmacy-controlled allocations, and coded identical containers for adequate concealment allocation. Administration of study drugs and infusion monitoring will be conducted by research nurse keeping blinding from investigators and independent outcome assessors.

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Mar 09, 2021 ACTUAL
    Primary Completion: Jun 18, 2024 ESTIMATED
    Completion Date: Dec 31, 2024 ESTIMATED
    Study First Posted: Sep 23, 2020 ACTUAL
    Last Updated: May 15, 2023

    Sponsors / Collaborators

    Lead Sponsor: VA Office of Research and Development
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Minneapolis, Minnesota, USA

    In this single site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine in conjunction with prolonged exposure (PE) therapy for PTSD. Veterans who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of two treatment arms (placebo plus PE vs ketamine plus PE). Participants receive the study drug via intravenous infusion once per week for 3-weeks.

    Participant Groups

    • Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.

    • Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * male or female Veterans between the ages of 18 and 75 years
    * diagnosis of PTSD
    * ability to provide written informed consent

    Exclusion Criteria:

    * females who are currently pregnant or breastfeeding
    * current high risk for suicide
    * history of moderate/severe head injury
    * history of psychosis
    * current episode of mania/hypomania
    * severe substance and/or alcohol use disorder in the last 6 months

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.

    More Details

    NCT Number: NCT04560660
    Other IDs: MHBP-006-19F
    Study URL: https://clinicaltrials.gov/study/NCT04560660
    Last updated: Sep 29, 2023