Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD

NCT04889664 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STUDY-21-00167
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 improvement in patients with chronic PTSD. WET is a brief, 5-session evidence-based written trauma-focused therapy without in between-session assignments, with demonstrated efficacy and low dropout rates in patients with PTSD. WET will be administered to all eligible participants; the first WET sessions will be interleaved with the last two ketamine infusions to take advantage of a window of increased neuroplasticity potentially induced by repeated ketamine infusions. WET will be administered on different days as the ketamine infusions.

Conditions

PTSD

Keywords

ketamine; Written Exposure Therapy; PTSD; intervention; treatment; posttraumatic stress disorder

Outcome Measures

Primary Outcomes (1)

• CAPS-5

  Clinician Administered PTSD Scale for DSM-5 (CAPS-5), assessed at baseline (before the first infusion) and 12 weeks following the start of WET. The Clinician-Administered PTSD Scale (CAPS) is a 30-item structured diagnostic interview designed to measure frequency and intensity of PTSD symptoms. The symptoms are scored in a 0-4 Likert-type scale, total score ranging from 0 to 80, higher score indicates more symptoms

  Baseline and Week 12

Study Arms (1)

Ketamine and Written Exposure Therapy

EXPERIMENTAL

Intravenous Ketamine 0.5 mg/kg and Written Exposure Therapy

Drug: Ketamine; Behavioral: Written Exposure Therapy

Interventions

Ketamine DRUG

Repeated intravenous Ketamine infusions.

Ketamine and Written Exposure Therapy

Written Exposure Therapy BEHAVIORAL

WET is a brief, 5-session evidence-based written trauma-focused therapy

Also known as: WET

Ketamine and Written Exposure Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai

Manhattan, New York, 10029, United States

Location

Related Publications (1)

• Feder A, Brown O, Rutter SB, Cahn L, Overbey JR, Seeley SH, Yu A, Bonanno PA, Fremont RA, Delgado AA, Jha MK, Costi S, Yehuda R, Schiller D, Pietrzak RH, Charney DS, Sloan DM, Murrough JW. Combining Ketamine Infusions and Written Exposure Therapy for Chronic PTSD: An Open-Label Trial. J Clin Psychiatry. 2025 Apr 2;86(2):24m15622. doi: 10.4088/JCP.24m15622.

  PMID: 40215385 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Adriana Feder
• Organization: Icahn School of Medicine at Mount Sinai

adriana.feder@mssm.edu

212-585-4661

Study Officials

• Adriana Feder, MD

  Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Oneysha Brown, BA

  Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asociate Professor Psychiatry

Model Details: Open label pilot study

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: June 4, 2021
• Primary Completion: October 14, 2023
• Study Completion: October 14, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Upon receipt of request by PI, and after obtaining the necessary Data Transfer Agreement, PI will provide requested de-identified data via CSV file.

Locations

US (1)