CAP-Ketamine for Antidepressant Resistant PTSD

Phase 2

Completed

• Conditions: PTSD; Posttraumatic Stress Disorder
• Interventions: Drug: Placebo/Saline; Drug: Ketamine

• Registration Number: NCT02655692
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-14
• Study Start: 2016-04-18
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Results First Submitted: 2021-10-25
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-06
• Last Update Submitted: 2022-05-06
• Results First Posted: 2022-06-02
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo/Saline	Saline dose
Low Dose Ketamine	Ketamine	Low Dose Ketamine (.20 mg/kg)
High Dose Ketamine	Ketamine	High Dose Ketamine (.50 mg/kg)

Primary Outcome Measures

Name	Time	Method
PTSD Checklist (PCL)	Session 1 -Day 0	The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD
The PTSD Checklist (PCL)	Follow-up 7 - Day 56	The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder (PTSD) to measure change in PTSD symptoms. The PCL-5 is a 20-item self-report measure, a total symptom severity score (range - 0-80) is obtained by summing the scores for each of the 20 items. (5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range 0-80) with higher scores indicating greater severity for PTSD

Secondary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	Follow-up 7 - Day 56	Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten-item diagnostic questionnaire to measure the severity of depression. The overall score ranges from 0 to 60 (0 to 6 - normal/symptom absent; 7 to 19 mild depression; 20 to 34 - moderate depression; \>34 - severe depression)

Trial Locations

Locations (3)

Brooke Army Medical Center; 🇺🇸 San Antonio, Texas, United States

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States