Overview

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

Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of the proposed study is to test if a single IV dose of ketamine (0.5 mg/kg) decreases symptoms of PTSD.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dennis Charney
Collaborator:
United States Department of Defense
Treatments:
Ketamine
Midazolam
Criteria
Inclusion Criteria:

- Men or women, 21-55 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-IV criteria for current civilian or combat-related PTSD,
based on clinical assessment by a study psychiatrist and on the CAPS (score must be at
least 50 at screening and prior to each infusion - this is done to ensure at least
moderate severity and to safeguard against high placebo response rates); additionally,
clinicians will use clinical judgment to assess if patients are symptomatic enough to
receive each infusion

- 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
pre-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 (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
infusion day;

- Use of evidence-based individual psychotherapy (such as prolonged exposure) and other
non-pharmacological treatments during the study;

- Histories 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 (given that this
might otherwise contribute to their symptoms, however, a rather narrow time period was
chosen such as 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);

- 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.