Ketamine and Prolonged Exposure in PTSD

NCT03960658 | Completed Phase 1 Results FDA Drug

• 1 other identifier: VAM-18-00333
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Severity of Post-traumatic Stress Disorder (PTSD) Symptoms

  The overall severity of PTSD symptoms would be measured by the mean change in the Past Month (current) total scores on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5) from baseline to post-treatment (10 weeks). The CAPS-5 is a structured interview with higher values representing worse outcomes. The CAPS-5 total symptom severity score ranges from 0 to 80 and it is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms.

  10 weeks

Secondary Outcomes (2)

• Change in Severity of Depressive Symptoms

  10 weeks

• Change in PTSD Symptoms for DSM-5

  10 weeks

Study Arms (1)

Ketamine and PE

EXPERIMENTAL

ketamine treatment followed by a standardized prolonged exposure session for the first 3 weeks; then, weekly prolonged exposure as usual.

Drug: ketamine-enhanced prolonged exposure

Interventions

ketamine-enhanced prolonged exposure DRUG

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.

Ketamine and PE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic (minimum of three months) PTSD (Clinician-Administered PTSD Scale for DSM-5 -CAPS-5 score\>33).
• Voluntarily eligible to participate in PE.
• Severity of PTSD symptoms defined by PCL-5\>33.
• Psychotropic medications on stable doses (no dosing adjustments/changes for ≥4 weeks; ≥6 weeks for fluoxetine) prior to prior to beginning of the study.

You may not qualify if:

• Unwillingness/unable to sign informed consent.
• Previous or current participation in trauma-exposed therapy and/or ketamine treatment.
• Evidence of mental retardation, pervasive developmental disorder and/or moderate/severe cognitive impairment (MMSE scores ≤27).
• Any unstable medical or non-psychiatric CNS condition.
• Lifetime history of psychosis-related disorder, bipolar disorder I or II disorder, or any condition other than PTSD judged to be the primary presenting psychiatric diagnosis.
• Moderate to severe traumatic brain injury (mental status change or loss of consciousness\>30 min; Glasgow Coma Scale \<13; post-traumatic amnesia\>24hours; visible lesion on CT/MRI brain scan).
• Active alcohol/illicit substance use disorder within 6 months of initial assessment; presence of illicit drugs by positive urine toxicology.
• For women: pregnancy (confirmed by lab test), initiation of female hormonal treatments within 3 months of screening, or inability/ unwillingness to use a medically accepted contraceptive method during the study.
• Imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead

Study Sites (1)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (1)

• Shiroma PR, Thuras P, Wels J, Erbes C, Kehle-Forbes S, Polusny M. A Proof-of-Concept Study of Subanesthetic Intravenous Ketamine Combined With Prolonged Exposure Therapy Among Veterans With Posttraumatic Stress Disorder. J Clin Psychiatry. 2020 Nov 10;81(6):20l13406. doi: 10.4088/JCP.20l13406. No abstract available.

  PMID: 33176074 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Paulo R. Shiroma
• Organization: Minneapolis VA Health Care System

paulo.shiroma@va.gov

612-467-2264

Study Officials

• Paulo R Shiroma, MD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Model Details: Open-label study

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 23, 2019
• Study Start: April 3, 2019
• Primary Completion: November 18, 2019
• Study Completion: December 4, 2019
• Last Updated: March 22, 2021
• Results First Posted: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)