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

Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: PTSD

Intervention: Ketamine (Drug); Midazolam (Drug)

Phase: Phase 2/Phase 3

Status: Withdrawn

Sponsored by: Adriana Feder

Official(s) and/or principal investigator(s):
Adriana Feder, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai


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.

Clinical Details

Official title: Randomized Controlled Trial of Repeated Dose Ketamine in Post Traumatic Stress Disorder (PTSD)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Impact of Events Scale-Revised (IES-R)

Secondary outcome:

Clinician Administered PTSD Scale (CAPS)

Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)

Montgomery Asberg Depression Rating Scale (MADRS)

Patient-Rated Inventory of Side Effects (PRISE)

Sheehan Disability Scale (SDS)

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: December 2014
Last updated: March 19, 2015

Page last updated: August 23, 2015

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