Ketamine and Prolonged Exposure in PTSD

• Status: Completed
• Trial end date: 2019-12-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Minneapolis Veterans Affairs Medical Center
• Treatments: Ketamine

Criteria

Inclusion Criteria:

1. Diagnosis of chronic (minimum of three months) PTSD (Clinician-Administered PTSD Scale for DSM-5 -CAPS-5 score>33).

2. Voluntarily eligible to participate in PE.

3. Severity of PTSD symptoms defined by PCL-5>33.

4. Psychotropic medications on stable doses (no dosing adjustments/changes for ≥4 weeks; ≥6 weeks for fluoxetine) prior to prior to beginning of the study.

Exclusion Criteria:

1. Unwillingness/unable to sign informed consent.

2. Previous or current participation in trauma-exposed therapy and/or ketamine treatment.

3. Evidence of mental retardation, pervasive developmental disorder and/or moderate/severe cognitive impairment (MMSE scores ≤27).

4. Any unstable medical or non-psychiatric CNS condition.

5. 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.

6. 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).

7. Active alcohol/illicit substance use disorder within 6 months of initial assessment; presence of illicit drugs by positive urine toxicology.

8. 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.

9. Imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan