Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress (KAPTIVATED)
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|ClinicalTrials.gov Identifier: NCT05344625|
Recruitment Status : Not yet recruiting
First Posted : April 25, 2022
Last Update Posted : November 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cancer-related Problem/Condition Depressive Symptoms Anxiety Disorders||Drug: Ketamine 100 MG/ML||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ketamine-Assisted Psychotherapy Viability in Treating Cancer-Related Emotional Distress|
|Estimated Study Start Date :||March 15, 2023|
|Estimated Primary Completion Date :||March 15, 2024|
|Estimated Study Completion Date :||March 15, 2024|
Experimental: Ketamine Assisted Psychotherapy
3 KAP sessions lasting approximately 3 hours using less than or equal to 60mg or 1mg/kg of intramuscular Ketalar as the facilitating chemical. KAP sessions will be supplemented with integration sessions occurring the following day and 1 month after the final KAP session.
Drug: Ketamine 100 MG/ML
Ketamine Assisted Psychotherapy
- Percentage of population completing at least one KAP session. [ Time Frame: Within 6 months from completion of radiation therapy ]The percentage of subjects who complete at least 1 session of KAP will be calculated, along with the associated 95% exact binomial confidence interval. The null hypothesis will be rejective if >50% of patients complete at least 1 KAP session.
- Depression and Anxiety [ Time Frame: Within 6 months from completion of radiation therapy ]GRID-HAM-D-17 for depression and the HAM-A for anxiety. These forms will be completed at baseline (time of enrollment), at the completion of the ketamine psychotherapy sessions, and at the completion of consolidative psychotherapy. A subject will be considered a responder if they have a 50% decrease from baseline in GRID-HAM-D-17 score for depression and a 50% decrease in HAM-A score for anxiety. At each timepoint subsequent to baseline, the percentage of subjects who are responders will be calculated, along with the associated 95% exact binomial confidence interval. If feasible, a subset analysis will be carried out for patients with GRID-HAM-D-17 scores of at least 22 or HAM-A scores at least 25 at baseline.
- Death and Dying Distress Scale (DADDS) [ Time Frame: Within 6 months from completion of radiation therapy ]The change from baseline in DADDS will be calculated at each timepoint subsequent to baseline, and summarized by calculating the median change, along with the first and third quartiles, and the minimum and maximum.
- Mystical Experience Questionnaire (MEQ-30) [ Time Frame: Within 6 months from completion of radiation therapy ]The MEQ-30 will be assessed after every KAP session, and summarized by calculating the median, along with the first and third quartiles, and the minimum and maximum. These values will be compared to historical controls in the psilocybin population for reference.
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): NCT05344625
|Contact: Jacob Eckstein, MDemail@example.com|
|Contact: Bhupesh Parashar, MDfirstname.lastname@example.org|