CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
ketamine-enhanced prolonged exposuredrug
Likely dose
ketamine-enhanced prolonged exposure 0.5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03960658
NCT03960658Phase 2Completed
CompareCT.gov

Repeated Sub-anesthetic Ketamine to Enhance Prolonged Exposure Therapy in Post-traumatic Stress Disorder: A Proof-of-concept Study

Minneapolis Veterans Affairs Medical Center·interventional·Posted May 23, 2019·Updated Mar 22, 2021

In Brief

A Phase 2 clinical trial evaluating ketamine-enhanced prolonged exposure for Post-traumatic Stress Disorder. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This study aims at investigating the effectiveness of the drug, Ketamine, in combination with Prolonged Exposure (PE) therapy for people suffering from PTSD. Participation in the study includes Ketamine infusions, which occur once a week for three weeks. PE therapy sessions will be scheduled one day after each infusion, and may continue up to 12 weeks. After completely therapy, there will be two monthly follow-up assessment visits.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-traumatic Stress Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 23, 2019
Enrollment StartApr 3, 2019
Primary CompletionNov 18, 2019
Study CompletionDec 4, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.1 years ago

Interventions

ketamine-enhanced prolonged exposuredrug

Subjects will receive a single infusion of racemic ketamine at 0.5mg/kg (ideal body weight) for 40 minutes. The next day, patients will have a standardized prolonged exposure session which lasts approximately 90 minutes. This co-jointed intervention will be repeated for 3 weeks. Then, patients will continue with therapy sessions to complete a total of 10-12 sessions.