We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Results First Posted : February 11, 2021
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Adriana Feder, Icahn School of Medicine at Mount Sinai

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder (PTSD) Drug: Ketamine Drug: Midazolam Phase 2 Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Repeated-Dose Intravenous Ketamine for PTSD
Study Start Date : May 18, 2015
Actual Primary Completion Date : January 27, 2020
Actual Study Completion Date : January 27, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Experimental ketamine group
This arm will receive 0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
 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
Active Comparator: Active control midazolam group
This arm will receive 0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks).
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: 2 weeks after the first infusion ]
    full range score from 0-80, with higher scores indicating greater PTSD symptoms


Secondary Outcome Measures :
  1. The Impact of Event Scale - Revised (IES-R) [ Time Frame: 24 hours after the first drug infusion ]
    full range score from 0-88, with higher scores indicating greater PTSD symptoms

  2. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours after the first drug infusion ]
    full range score from 0-60, with higher scores indicating greater depressive symptoms

  3. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 2 weeks after the first drug infusion ]
    full range score from 0-60, with higher scores indicating greater depressive symptoms

  4. Quick Inventory of Depression Symptomatology - Self-Report (QIDS-SR) [ Time Frame: 2 weeks after the first drug infusion ]
    full range score from 0-27, with higher scores indicating greater depressive symptoms

  5. Number of Participants With Patient-Rated Inventory of Side Effects (PRISE) [ Time Frame: up to 21 weeks ]
    All side effects listed in Adverse Event section.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397889


Locations
Layout table for location information
United States, New York
Depression and Anxiety Center (DAC)
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Layout table for investigator information
Principal Investigator: Adriana Feder, MD Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

Documents provided by Adriana Feder, Icahn School of Medicine at Mount Sinai:
Study Protocol and Statistical Analysis Plan  [PDF] January 24, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Adriana Feder, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02397889    
Other Study ID Numbers: GCO 15-0265
First Posted: March 25, 2015    Key Record Dates
Results First Posted: February 11, 2021
Last Update Posted: March 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Adriana Feder, Icahn School of Medicine at Mount Sinai:
posttraumatic stress disorder
PTSD
ketamine
trauma
 treatment
New York
NYC
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents