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Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)

NCT02397889 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-03-11

Study results available
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Summary

The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. The purpose of this study is to see whether ketamine, when given repeatedly intravenously can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD. Ketamine given for PTSD is investigational, which means that the FDA has not yet approved the drug for treating this condition. In this study, the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute anesthetic effects compared to ketamine but has not been shown to treat or alleviate any symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can treat or alleviate PTSD symptoms thereby acting as what we call an active control.

Conditions

  • Posttraumatic Stress Disorder (PTSD)

Interventions

DRUG

Ketamine

This arm will receive 0.5mg/kg repeated dose ketamine (6 intravenous infusions, 3 per week for 2 weeks).

DRUG

Midazolam

This arm will receive 0.045mg/kg repeated dose intravenous midazolam (6 intravenous infusions, 3 per week for 2 weeks).

Sponsors & Collaborators

Principal Investigators

  • Adriana Feder, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-18
Primary Completion
2020-01-27
Completion
2020-01-27

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02397889 on ClinicalTrials.gov