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To Test the Potential Efficacy of Repeated Intranasal Administration of Ketamine as a Treatment for PTSD

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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Recruitment Status : Withdrawn (FDA and IRB recommended different mode of medication administration)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

Tracking Information
First Submitted Date  ICMJE November 7, 2014
First Posted Date  ICMJE March 25, 2015
Last Update Posted Date March 25, 2015
Study Start Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
  • Sheehan Disability Scale (SDS) [ Time Frame: 24 hours ]
    The SDS is a 10 point visual analog scale developed to assess functional impairment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Test the Potential Efficacy of Repeated Intranasal Administration of Ketamine as a Treatment for PTSD
Official Title  ICMJE Randomized Controlled Trial of Repeated Dose Ketamine in Post Traumatic Stress Disorder (PTSD)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE
  • Drug: Ketamine
    Other Name: Intranasal ketamine
  • Drug: Midazolam
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Ketamine
    Intranasal ketamine up to 75 mg, delivered over 20 minutes, frequency: 3x/week for 4 weeks.
    Intervention: Drug: Ketamine
  • Active Comparator: Midazolam
    Intranasal midazolam 3.75mg, delivered over 20 minutes, frequency: 3x/week for 4 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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 19, 2015)
0
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (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, 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.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02398136
Other Study ID Numbers  ICMJE GCO 14-1781
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adriana Feder, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Adriana Feder
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 March 2015

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