PTSD
Conditions
Keywords
Post-traumatic Stress Disorder
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.
Detailed description
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.
Interventions
DRUGKetamine
FDA approved anesthetic medication with rapid acting antidepressant effects.
DRUGMidazolam
FDA approved sedative medication with dissociative effects.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Baseline | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPaulo R Shiroma, MD
Minneapolis VA Health Care System, Minneapolis, MN
Participant flow
Pre-assignment details
73 participants were randomized and received at least one treatment infusion
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.7 years STANDARD_DEVIATION 11.4 |
| Beck Anxiety Inventory (BAI) | 31.7 units on a scale STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | 32.9 units on a scale STANDARD_DEVIATION 7.3 |
| PTSD Checklist for DSM-5 (PCL-5) | 56.7 units on a scale STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 65 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 36 |
| other Total, other adverse events | 33 / 37 | 34 / 36 |
| serious Total, serious adverse events | 1 / 37 | 1 / 36 |
Outcome results
None listed