Connectivity Changes Associated With Ketamine... — Clinical Trial Details

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Inclusion Criteria:
Between the ages of 18 to 65 years old.
Meet DSM-5 criteria for Post-Traumatic Stress Disorder (PTSD) based on clinical interview.
Able to provide informed consent.
Are proficient in reading and speaking English.
Agree to refrain from using stimulants during the day of the medication session.
Agree to refrain from alcohol and cannabis for 24 hours before and the day of medication session.
Subjects taking other psychotropic medications must be maintained on a stable dose for at least four weeks before study initiation.
Agree to not operate a car or any other heavy equipment for the rest of the day after the ketamine administration.
If necessary, are willing to be contacted via telephone on a daily basis by the therapist or team after each experiential session.
Able to identify one or two caregiver support persons who can drive participant home, stay with them overnight, be reached by the team, and provide collateral information as needed.
Willing to inform the investigator within 48 hours if any medical conditions occur or procedures are planned.

Exclusion Criteria

Exclusion Criteria:
Considered an immediate suicide risk by clinician assessment or felt to be likely to require hospitalization during the study.
Psychiatric or medical hospitalization, or an Emergency Department visit, within four weeks of study entry.
Meet DSM-5 criteria for current bipolar disorder based on clinical interview.
Meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview.
Meeting DSM-5 criteria for current substance use disorder (not in early or sustained remission) other than tobacco use disorder.
Report use of ketamine >20 times in the past or meet DSM-5 criteria for Other Hallucinogen Use Disorder due to ketamine use, including current early or sustained remission.
Women who are pregnant or nursing, and women who do not consent to use methods of highly effective birth control during the study.
Hypertension defined as baseline SBP >140 mmHg or DBP >90 mmHg.
History of allergic or other adverse reaction to ketamine (or its excipients).
Clinically significant physical exam findings or medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g., glaucoma, aneurysmal disease, cardiovascular disease, end-stage renal disease).
QTc 450 ms or longer on screening.
High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).
Documented significant renal or hepatic dysfunction at screening per protocol-defined thresholds.
Blood pressure must be ≤140/90 mmHg at safety screening on day of drug administration sessions.

Company

Product

Legal

Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

KAP

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators