None listed
Conditions
Brief summary
Posttraumatic Stress Disorder (PTSD) is a severe mental disorder that can develop following exposure to trauma, significantly impacting psychosocial and vocational functioning and often proving chronic. In the Otago region alone, approximately 15 thousand individuals are expected to experience PTSD in their lifetime. Current treatments for PTSD are only partially effective, with as many as 60% of patients not fully recovering following standard psychotherapeutic interventions. Recent research into pharmaceutical treatments has shown that Ketamine (K) can rapidly alleviate PTSD symptoms, though its common administration methods—intravenous or intramuscular injections—are associated with unpleasant side effects. Oral K is now being investigated as an alternative to intravenous or intramuscular routes of administration due to its lower side effect profile, ease of administration, and cost-effectiveness. Despite promising preliminary findings suggesting that oral K is of therapeutic benefit for PTSD symptoms, more research is necessary to confirm these effects and determine the amount and duration of symptom relief. The current feasibility study aims to assess participant recruitment and an oral K dosing regimen for PTSD, as well as exploring the subjective experiences of participants that can be used in designing future trials. The study will incorporate Maori tikanga principles and seek feedback on the inclusivity of the protocol. Participants with moderate to severe PTSD from the Otago region will be recruited. The expected outcomes include developing improved or new pharmaceutical treatment regimen for better health outcomes in PTSD and informing a larger study in Otago and Canterbury that will evaluate the combination of oral K with psychotherapy for sustained PTSD remission. These benefits are likely to be accomplished within the next 1- 2-year time frame.
Interventions
In the present study we propose investigating the feasibility of the use of a particular oral Ketamine (Ketalar® active ingredient: Ketamine hydrochloride). Dosing regimen with start with 5 consecutive days of stepwise increases of oral Ketamine from .5 to 2mg/kg (for example .5mg/kg for 1 day, 1mg/kg for 2 days, 1.5mg/kg for 1 day and 2mg/kg for 1 day) as tolerated; then 2mg/kg twice weekly for a further 10 weeks. The oral ketamine will be sipped with orange juice over a period of an hour under
In the present study we propose investigating the feasibility of the use of a particular oral Ketamine (Ketalar® active ingredient: Ketamine hydrochloride). Dosing regimen with start with 5 consecutive days of stepwise increases of oral Ketamine from .5 to 2mg/kg (for example .5mg/kg for 1 day, 1mg/kg for 2 days, 1.5mg/kg for 1 day and 2mg/kg for 1 day) as tolerated; then 2mg/kg twice weekly for a further 10 weeks. The oral ketamine will be sipped with orange juice over a period of an hour under the supervision of research staff. The aim is to reduce PTSD symptoms in a population currently experiencing moderate to severe PTSD.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
To be included in the study, participants must meet all the following inclusion criteria: 1. Adult between 18 and 50 years of age. 2. Capable of understanding and signing an informed consent. 3. Have experienced a traumatic event and currently meet criteria for moderate-severe PTSD: a score of greater than or equals to 23 on the PTSD Symptom Scale Interview for DSM-5 (PSSI-5).
Exclusion criteria
To be included in the study, participants must meet none of the following exclusion criteria: 1. Evidence of severe acute or chronic medical disorders. 2. Past or current diagnoses of schizophrenia, bipolar disorder, or current psychotic symptoms. 3. Current diagnosis of severe personality disorder. 4. Be pregnant or lactating. 5. Had drug abuse or dependence in the last 6 months. 6. Screening suggests that primary motivation for involvement in the study is seeking access to ketamine. 7. current significant suicidal ideation. 8. participants must be free of recreational drug and alcohol use at the time of testing. 9. Are under current psychotherapy treatment for PTSD.
Outcome results
None listed