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Ketamine and Prolonged Exposure in PTSD

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ClinicalTrials.gov Identifier: NCT03960658
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Paulo Shiroma, Minneapolis Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Drug: ketamine-enhanced prolonged exposure Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repeated Sub-anesthetic Ketamine to Enhance Prolonged Exposure Therapy in Post-traumatic Stress Disorder: A Proof-of-concept Study
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine and PE
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
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.




Primary Outcome Measures :
  1. Change in severity of Post-traumatic Stress Disorder (PTSD) symptoms [ Time Frame: 10 weeks ]
    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), a 30-item structured interview with higher values representing worse outcomes.


Secondary Outcome Measures :
  1. Change in severity of depressive symptoms [ Time Frame: 10 weeks ]
    Total score on the Montgomery- Åsberg Depression Rating Scale , a semi- structured 10-item scale. Range 0-60. Higher values represent worse outcomes.

  2. Change in illness severity and improvement [ Time Frame: 10 weeks ]
    The Clinical Global Impression is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse).

  3. Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score [ Time Frame: 10 weeks ]
    CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive performance. We will include attention, executive and memory functions. CogState CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions.

  4. Change in fear activation and extinction during PE sessions [ Time Frame: 10 weeks ]
    Subjective units of distress (SUDS), a self-rating measure of distress ranging from 0 (complete relaxation) to 100 (maximum distress). and will measure activation of fear structure, decrease in fear during exposure sessions (within-session extinction); and decrease in initial reactions to the feared stimuli across sessions (between- session extinction). SUDS ratings correspond well with other indices of fear expression, including physiological indicators.

  5. Frequency, intensity and burden of general Adverse Events [ Time Frame: 10 weeks ]
    Frequency, Intensity, and Burden of Side Effects Rating (FIBSER), a self-reported questionnaire of the burden due to side effects in a 7-point Likert-type scale. Higher values represents worse outcome. Range: 0-18

  6. Change in the Patient's Credibility and Expectation of Outcome Treatment (CEQ). [ Time Frame: pre-intervention ]
    CEQ is an 8-item scale of belief in the rationale and logic of a treatment (credibility) and belief in a likely positive outcome from a treatment (expectancy). Higher values represent better credibility and expectations.Items 1 and 3 of the CEQ Expectancy scale have a 0-100% scale, and item 2 has a 1-9 rating scale. After transforming the percentage scales, the total sum score ranges from 3 to 27.

  7. Change in severity of Anxiety [ Time Frame: 10 weeks ]
    Beck Anxiety Inventory, a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety. Range: 0-63. Higher values represent worse outcomes.

  8. Change in PTSD symptoms for DSM-5 [ Time Frame: 10 weeks ]
    The PTSD Checklist for DSM-5 (PCL5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Range from 0-80. Higher values represent worse outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960658


Contacts
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Contact: Eric Baltutis, BA 612-467-2974 eric.baltutis@va.gov

Locations
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United States, Minnesota
Minneapolis VA Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Eric Baltutis, BA    612-467-2974    eric.baltutis@va.gov   
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Investigators
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Principal Investigator: Paulo R Shiroma, MD Minneapolis Veterans Affairs Medical Center

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Responsible Party: Paulo Shiroma, Clinical Investigator, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03960658     History of Changes
Other Study ID Numbers: VAM-18-00333
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action