Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Test the Potential Efficacy of Repeated Intranasal Administration of Ketamine as a Treatment for 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: NCT02398136
Recruitment Status : Withdrawn (FDA and IRB recommended different mode of medication administration)
First Posted : March 25, 2015
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Adriana Feder, Icahn School of Medicine at Mount Sinai

Brief Summary:
The purpose of this study is to see whether ketamine, when given repeatedly via the nose (intranasally), 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.

Condition or disease Intervention/treatment Phase
PTSD Drug: Ketamine Drug: Midazolam Phase 2 Phase 3

Detailed Description:
The objective of the present research protocol, a parallel-arm, double-blind, randomized controlled clinical trial, is to test the efficacy of repeated intranasal administration of the glutamatergic NMDA receptor antagonist ketamine in providing (1) rapid relief of and (2) sustained improvement in core PTSD symptoms and co-morbid depressive symptoms in patients with chronic PTSD. The effects of ketamine will be compared with those of repeated intranasal administration of the benzodiazepine anesthetic midazolam, which mimics some of the acute subjective effects of ketamine but is expected to have lesser or less sustained anxiolytic effect, and no sustained antidepressant effect.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Repeated Dose Ketamine in Post Traumatic Stress Disorder (PTSD)
Study Start Date : December 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketamine
Intranasal ketamine up to 75 mg, delivered over 20 minutes, frequency: 3x/week for 4 weeks.
Drug: Ketamine
Other Name: Intranasal ketamine

Active Comparator: Midazolam
Intranasal midazolam 3.75mg, delivered over 20 minutes, frequency: 3x/week for 4 weeks.
Drug: Midazolam
Other Name: Placebo




Primary Outcome Measures :
  1. Impact of Events Scale-Revised (IES-R) [ Time Frame: 24 hours ]
    The IES-R is used to self-report measures of stress reactions to traumatic events. It measures both intrusion and avoidance.


Secondary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS) [ Time Frame: up to 4 weeks ]
    The CAPS is a structured clinical interview designed to assess the essential features of PTSD.

  2. Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) [ Time Frame: 24 hours ]
    The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days.

  3. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ]
    The MADRS is a 10-item instrument used for the evaluation of depressive symptoms and for the assessment of any changes to those symptoms.

  4. Patient-Rated Inventory of Side Effects (PRISE) [ Time Frame: 24 hours ]
    PRISE is a 7-item self report used to qualify side effects by identifying and evaluating the tolerability of each symptoms.

  5. Sheehan Disability Scale (SDS) [ Time Frame: 24 hours ]
    The SDS is a 10 point visual analog scale developed to assess functional impairment.



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, based on clinical assessment by a study psychiatrist and on the CAPS -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 intranasal administration;
  • 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 (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;
  • Patients with uncorrected hypothyroidism or hyperthyroidism;
  • Hormonal treatment (e.g., estrogen) started in the 3 months prior to the first intranasal administration 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; a rather narrow time period was chosen, however, in order to allow participation by individuals with a history of substance abuse or dependence problems that could be secondary to their PTSD, and to more closely approximate patients seen in real-world settings; this is the same period of time that we used in our recently completed study of IV ketamine for PTSD.
  • Previous recreational use of ketamine or PCP;
  • Current diagnosis of bulimia nervosa or anorexia nervosa;
  • Diagnosis of schizotypal or antisocial personality disorder (since these are known to reduce the possibility of study completion); other Axis II diagnoses will be allowed;
  • 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; patients taking stable doses of antidepressant medication for 3 months prior to randomization will be allowed.
  • For subjects who may participate in the MRI portion of the study, claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, and inability to lie still for 1 hour or more.

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): NCT02398136


Sponsors and Collaborators
Adriana Feder
Investigators
Layout table for investigator information
Principal Investigator: Adriana Feder, MD Icahn School of Medicine at Mount Sinai
Layout table for additonal information
Responsible Party: Adriana Feder, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02398136    
Other Study ID Numbers: GCO 14-1781
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Adriana Feder, Icahn School of Medicine at Mount Sinai:
intervention
ketamine
PTSD
treatment
posttraumatic stress disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Ketamine
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Midazolam
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