Ketamine and Prolonged Exposure in PTSD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03960658|
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-traumatic Stress Disorder||Drug: ketamine-enhanced prolonged exposure||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label study|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
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
|Contact: Eric Baltutis, BAfirstname.lastname@example.org|
|United States, Minnesota|
|Minneapolis VA Medical Center||Recruiting|
|Minneapolis, Minnesota, United States, 55417|
|Contact: Eric Baltutis, BA 612-467-2974 email@example.com|
|Principal Investigator:||Paulo R Shiroma, MD||Minneapolis Veterans Affairs Medical Center|