Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
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|ClinicalTrials.gov Identifier: NCT02397889|
Recruitment Status : Completed
First Posted : March 25, 2015
Results First Posted : February 11, 2021
Last Update Posted : March 11, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder (PTSD)||Drug: Ketamine Drug: Midazolam||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Experimental: Experimental ketamine group
This arm will receive 0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks).
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).
This arm will receive 0.045mg/kg repeated dose intravenous midazolam (6 intravenous infusions, 3 per week for 2 weeks).
Other Name: Generic only
- 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
- 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
- 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
- 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
- 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
- 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.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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
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
|United States, New York|
|Depression and Anxiety Center (DAC)|
|New York, New York, United States, 10029|
|Principal Investigator:||Adriana Feder, MD||Icahn School of Medicine at Mount Sinai|
Documents provided by Adriana Feder, Icahn School of Medicine at Mount Sinai:
|Responsible Party:||Adriana Feder, Associate Professor, Icahn School of Medicine at Mount Sinai|
|Other Study ID Numbers:||
|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|
posttraumatic stress disorder
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives