Adding Trauma-focused Psychotherapy to Ketamine... — Clinical Trial Details

Single-group, open-label pilot in adults with chronic PTSD receiving a course of six intravenous ketamine infusions (0.5 mg/kg) plus five sessions of Written Exposure Therapy (WET), with WET sessions interleaved with the final two infusions.

Primary outcome is change in PTSD severity (CAPS-5) from baseline to 12 weeks after the start of WET; participants assessed weekly to 12 weeks and monthly up to 24 weeks if improved. The study will also explore whether extinction-learning performance predicts maintenance of ketamine response.

Participants

Ages

18 – 70

Sexes

Male & Female

BMI

0 - 40

Psychosis History

Inclusion Criteria

Inclusion Criteria:
1. Men or women, 18-70 years of age;
2. Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document;
3. Participants must fulfil DSM-5 criteria for current civilian or combat-related PTSD, based on clinical assessment by a study psychiatrist and on the CAPS-5, and a past-month total CAPS-5 score ≥ 30 at screening;
4. Women must be using a medically accepted reliable means of contraception (if using an oral contraceptive medication, they must also be using a barrier contraceptive) or not be of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year);
5. Women of childbearing potential must have a negative pregnancy test at screening and prior to each intravenous infusion;
6. Men who are sexually active with women of childbearing potential must use a medically accepted reliable means of contraception and must agree not to donate sperm for a period of 90 days after receiving the last dose of ketamine;
7. Participants must be able to identify a family member, physician, or friend who will participate in a Treatment Contract (and e.g. contact the study physician on their behalf in case manic symptoms or suicidal thoughts develop).

Exclusion Criteria

Exclusion Criteria:
1. Women who plan to become pregnant, are pregnant or are breast-feeding;
2. Serious, unstable medical illnesses such as hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, including gastro-esophageal reflux disease, obstructive sleep apnea, history of difficulty with airway management during previous anesthetics, ischemic heart disease and uncontrolled hypertension, and history of severe head injury;
3. Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
4. Renal impairment, as reflected by a BUN >20 mg/dL, and/or creatinine clearance of >1.3 mg/dL;
5. Clinically significant uncorrected hypothyroidism or hyperthyroidism, as indicated by a TSH value 25% above or below the normal range;
6. A Body Mass Index (BMI) >40;
7. Hormonal treatment (e.g., estrogen) started in the 3 months prior to the first infusion day;
8. History of a neurodevelopmental disorder (e.g., autism, pervasive developmental disorder);
9. History of one or more seizures without a clear and resolved etiology;
10. Lifetime history of bipolar I or II disorder;
11. Presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia or schizoaffective disorder;
12. Drug or alcohol use disorder within the preceding 3 months;
13. Previous recreational use of ketamine or PCP on more than one occasion, or any recreational use of ketamine or PCP within the last two years;
14. Previous non-response to clinical or research ketamine or esketamine administration;
15. Current diagnosis of bulimia nervosa or anorexia nervosa;
16. Patients judged clinically to be at serious and imminent suicidal or homicidal risk;
17. SBP >165 and DBP >95 at infusion days;
18. Concurrent treatment with opioid medication, or with long-acting or daytime short-acting benzodiazepines within two weeks of study start;
19. Current cognitive impairment, as defined by a score <23 on the Montreal Cognitive Assessment (MoCA);
20. Estimated IQ <80;
21. Currently receiving evidence-based psychotherapy for PTSD (e.g., prolonged exposure, cognitive processing therapy);
Note: Concurrent treatment with other psychotropic medications (including a short-acting benzodiazepine at bedtime only) will be permitted, but dose must be stabilised for at least three months before study start.

Company

Product

Legal

Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Ketamine + WET

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators