Status:
COMPLETED
Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
PTSD
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The current pilot project will evaluate the efficacy of adding Written Exposure Therapy (WET) to a course of repeated IV ketamine infusions in improving PTSD symptoms and maintaining symptom improveme...
Detailed Description
Current treatments for PTSD do not work for a significant proportion of individuals with PTSD, or work only partially, leaving persistent and disabling residual symptoms. The research team has led the...
Eligibility Criteria
Inclusion
- Men or women, 18-70 years of age;
- 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;
- Participants must fulfill 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 CAPS5 score ≥ 30 at screening - this is done to ensure at least moderate severity and to safeguard against high placebo response rates;
- 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);
- Women of childbearing potential must have a negative pregnancy test at screening and prior to each intravenous infusion;
- 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;
- Participants must be able to identify a family member, physician, or friend (i.e. someone who knows them well) 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
- Women who plan to become pregnant, are pregnant or are breast-feeding (because the medical risk of using ketamine during pregnancy and breast-feeding is unknown);
- 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;
- Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
- Renal impairment, as reflected by a BUN \>20 mg/dL, and/or creatinine clearance of \>1.3 mg/dL;
- Clinically significant uncorrected hypothyroidism or hyperthyroidism, as indicated by a TSH value 25% above or below the normal range;
- A Body Mass Index (BMI) \>40;
- Hormonal treatment (e.g., estrogen) started in the 3 months prior to the first infusion day;
- History of a neurodevelopmental disorder (e.g., autism, pervasive developmental disorder) ;
- History of one or more seizures without a clear and resolved etiology;
- Lifetime history of bipolar I or II disorder;
- Presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia or schizoaffective disorder;
- Drug or alcohol use disorder within the preceding 3 months
- 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;
- Previous non-response to clinical or research ketamine or esketamine administration;
- Current diagnosis of bulimia nervosa or anorexia nervosa;
- Patients judged clinically to be at serious and imminent suicidal or homicidal risk;
- SBP \>165 and DBP \>95 at infusion days - higher BP allowed to account for stress or anxiety;
- Concurrent treatment with opioid medication, or with long-acting or daytime short-acting benzodiazepines within two weeks of study start;
- Current cognitive impairment, as defined by a score \<23 on the Montreal Cognitive Assessment (MoCA);
- Estimated IQ \<80;
- 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 stabilized for at least three months before study start.
Key Trial Info
Start Date :
June 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04889664
Start Date
June 4 2021
End Date
October 14 2023
Last Update
October 8 2024
Active Locations (1)
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1
Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai
Manhattan, New York, United States, 10029