CAP-Ketamine for Antidepressant Resistant PTSD

VA Office of Research and Development

Status and phase: Completed; Phase 2

Conditions: Posttraumatic Stress Disorder; PTSD

Treatments: Drug: Placebo/Saline; Drug: Ketamine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02655692

SPLE-003-14W

Details and patient eligibility

About

The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an active duty military and Veteran population.

Full description

In this 2-site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine for treatment resistant PTSD, Veterans and active duty military personnel who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of three treatment arms (placebo, low dose ketamine, high dose ketamine). Participants receive the study drug via intravenous infusion twice per week for 4-weeks.

Enrollment: 163 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female Veterans or active duty military personnel between the ages of 18 and 70 years
• diagnosis of PTSD
• history of trialing one or more antidepressant medications with little to no PTSD symptom improvement
• ability to provide written informed consent

Exclusion criteria

• females who are currently pregnant or breastfeeding
• current high risk for suicide
• history of severe head injury

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

163 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline dose

Treatment:

Drug: Placebo/Saline

Low Dose Ketamine

Experimental group

Description:

Low Dose Ketamine (.20 mg/kg)

Treatment:

Drug: Ketamine

High Dose Ketamine

Experimental group

Description:

High Dose Ketamine (.50 mg/kg)

Treatment:

Drug: Ketamine