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Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397889
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Adriana Feder, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE March 19, 2015
First Posted Date  ICMJE March 25, 2015
Last Update Posted Date March 3, 2020
Study Start Date  ICMJE May 2015
Actual Primary Completion Date January 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
Clinician Administered PTSD Scale (CAPS) [ Time Frame: 2 weeks after the first infusion ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2015)
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 1 week after the first infusion ]
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 2 weeks after the first infusion ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
  • The Impact of Event Scale - Revised (IES-R) [ Time Frame: 24 hours after the first drug infusion ]
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours after the first drug infusion ]
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 2 weeks after the first drug infusion ]
  • Patient-Rated Inventory of Side Effects (PRISE) [ Time Frame: up to 21 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2015)
  • The Impact of Event Scale - Revised (IES-R) [ Time Frame: 24 hours post-infusion ]
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours after the first drug infusion ]
  • Patient-Rated Inventory of Side Effects (PRISE) [ Time Frame: up to 21 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
Official Title  ICMJE Randomized Controlled Trial of Repeated-Dose Intravenous Ketamine for PTSD
Brief Summary The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. The purpose of this study is to see whether ketamine, when given repeatedly intravenously can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD. Ketamine given for PTSD is investigational, which means that the FDA has not yet approved the drug for treating this condition. In this study, the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute anesthetic effects compared to ketamine but has not been shown to treat or alleviate any symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can treat or alleviate PTSD symptoms thereby acting as what we call an active control.
Detailed Description

Ketamine is an approved medication in several countries for the induction of general anesthesia and for use as adjunct to other anesthetics. Intravenous ketamine is being developed and tested for the treatment of posttraumatic stress disorder (PTSD).

All subjects will be administered the study medication by the study anesthesiologists and under the direct supervision of the investigator or designee. On all dosing days, all subjects must remain at the clinical site until at least 4 hours post-dose (or longer if required for study procedures) and will be accompanied by a responsible adult when discharged from the clinical site. The end of study will occur when the last subject in the trial completes his/her last study assessment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder (PTSD)
Intervention  ICMJE
  • Drug: Ketamine
    This arm will receive 0.5mg/kg repeated dose ketamine (6 intravenous infusions, 3 per week for 2 weeks).
    Other Name: Generic only
  • Drug: Midazolam
    This arm will receive 0.045mg/kg repeated dose intravenous midazolam (6 intravenous infusions, 3 per week for 2 weeks).
    Other Name: Generic only
Study Arms  ICMJE
  • Experimental: Experimental ketamine group
    This arm will receive 0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
    Intervention: Drug: Ketamine
  • Active Comparator: Active control midazolam group
    This arm will receive 0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2015)
40
Actual Study Completion Date  ICMJE January 27, 2020
Actual Primary Completion Date January 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women, 18-65 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
  • 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;
  • 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 criteria:

  • Women who plan to become pregnant, are pregnant or are breast-feeding
  • 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 creatinin clearance of >1.3 mg/dL;
  • Thyroid impairment, as reflected by TSH> 4.2 mU/L Patients with uncorrected hypothyroidism or hyperthyroidism;
  • Hormonal treatment (e.g., estrogen) started in the 3 months prior to the first infusion day;
  • Use of evidence-based individual psychotherapy (such as prolonged exposure) during the study;
  • History of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome; History of one or more seizures without a clear and resolved etiology;
  • History of (hypo)mania;
  • Past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia or schizoaffective disorder;
  • Drug or alcohol abuse or dependence within the preceding 3 months
  • Previous recreational use of ketamine or PCP;
  • Current diagnosis of bulimia nervosa or anorexia nervosa;
  • Diagnosis of schizotypal or antisocial personality disorder
  • Patients judged clinically to be at serious and imminent suicidal or homicidal risk.
  • A blood pressure of one reading over 160/90 or two separate readings over 140/90 at screen or baseline visits
  • Patients who report current treatment with a benzodiazepine, an opioid medication, or a mood stabilizer (such as valproic acid or lithium) within 2 weeks prior to randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02397889
Other Study ID Numbers  ICMJE GCO 15-0265
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adriana Feder, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adriana Feder, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP