Posttraumatic Stress Disorder (PTSD)Phase 2/3NCT02397889
Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
A Phase 2/3 study testing Ketamine and Midazolam in people with Posttraumatic Stress Disorder (PTSD), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2015to 27 Jan 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression and Anxiety Center (DAC)
New York, New York, 10029
About this study
Official title: Randomized Controlled Trial of Repeated-Dose Intravenous Ketamine for PTSD
The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. The purpose of this study is to see whether ketamine, when given repeatedly intravenously 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. Ketamine given for PTSD is investigational, which means that the FDA has not yet approved the drug for treating this condition. In this study, the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute anesthetic effects compared to ketamine but has not been shown to treat or alleviate any symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can treat or alleviate PTSD symptoms thereby acting as what we call an active control.
Read the detailed description
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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- posttraumatic stress disorder, PTSD, ketamine, trauma, treatment, New York, NYC
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Generic only
This arm will receive 0.5mg/kg repeated dose ketamine (6 intravenous infusions, 3 per week for 2 weeks).
MidazolamDrug
Also called Generic only
This arm will receive 0.045mg/kg repeated dose intravenous midazolam (6 intravenous infusions, 3 per week for 2 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Experimental ketamine group | Experimental | This arm will receive 0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks). Receives: Drug: Ketamine |
| Active control midazolam group | Active comparator | This arm will receive 0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks). Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
full range score from 0-80, with higher scores indicating greater PTSD symptoms
Measured: 2 weeks after the first infusion
Secondary outcomes (5)
The Impact of Event Scale - Revised (IES-R)
full range score from 0-88, with higher scores indicating greater PTSD symptoms
Measured: 24 hours after the first drug infusion
Montgomery Asberg Depression Rating Scale (MADRS)
full range score from 0-60, with higher scores indicating greater depressive symptoms
Measured: 24 hours after the first drug infusion
Montgomery Asberg Depression Rating Scale (MADRS)
full range score from 0-60, with higher scores indicating greater depressive symptoms
Measured: 2 weeks after the first drug infusion
Quick Inventory of Depression Symptomatology - Self-Report (QIDS-SR)
full range score from 0-27, with higher scores indicating greater depressive symptoms
Measured: 2 weeks after the first drug infusion
Number of Participants With Patient-Rated Inventory of Side Effects (PRISE)
All side effects listed in Adverse Event section.
Measured: up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study start18 May 2015
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Feder, Icahn School of Medicine at Mount Sinai
- Investigators
- Adriana Feder, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397889
- Sponsor's protocol ID
- GCO 15-0265
- Status last verified
- Feb 2021
- First submitted
- 19 Mar 2015
- Last updated
- 11 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Feder A, Costi S, Rutter SB, Collins AB, Govindarajulu U, Jha MK, Horn SR, Kautz M, Corniquel M, Collins KA, Bevilacqua L, Glasgow AM, Brallier J, Pietrzak RH, Murrough JW, Charney DS. A Randomized Controlled Trial of Repeated Ketamine Administration for Chronic Posttraumatic Stress Disorder. Am J Psychiatry. 2021 Feb 1;178(2):193-202. doi: 10.1176/appi.ajp.2020.20050596. Epub 2021 Jan 5.
PubMed 33397139
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Repeated-Dose Intravenous Ketamine for PTSD
- ClinicalTrials.gov ID
- NCT02397889
- Acronym / sponsor ID
- GCO 15-0265
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- posttraumatic stress disorder, PTSD, ketamine, trauma, treatment, New York, NYC
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 18 May 2015
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Posted 11 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. The purpose of this study is to see whether ketamine, when given repeatedly intravenously 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. Ketamine given for PTSD is investigational, which means that the FDA has not yet approved the drug for treating this condition. In this study, the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute anesthetic effects compared to ketamine but has not been shown to treat or alleviate any symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can treat or alleviate PTSD symptoms thereby acting as what we call an active control.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental ketamine group | Experimental | Drug: KetamineThis arm will receive 0.5mg/kg repeated dose ketamine (6 infusions, 3 per week for 2 weeks). |
| Active control midazolam group | Active comparator | Drug: MidazolamThis arm will receive 0.045mg/kg repeated dose midazolam (6 infusions, 3 per week for 2 weeks). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Generic onlyThis arm will receive 0.5mg/kg repeated dose ketamine (6 intravenous infusions, 3 per week for 2 weeks). | Drug | Experimental ketamine group |
| MidazolamAlso: Generic onlyThis arm will receive 0.045mg/kg repeated dose intravenous midazolam (6 intravenous infusions, 3 per week for 2 weeks). | Drug | Active control midazolam group |
Primary outcome
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
5 secondary outcomes
The Impact of Event Scale - Revised (IES-R)
Time frame: 24 hours after the first drug infusion
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: 24 hours after the first drug infusion
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: 2 weeks after the first drug infusion
Quick Inventory of Depression Symptomatology - Self-Report (QIDS-SR)
Time frame: 2 weeks after the first drug infusion
Number of Participants With Patient-Rated Inventory of Side Effects (PRISE)
Time frame: up to 21 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33397139Feder A, Costi S, Rutter SB, Collins AB, Govindarajulu U, Jha MK, Horn SR, Kautz M, Corniquel M, Collins KA, Bevilacqua L, Glasgow AM, Brallier J, Pietrzak RH, Murrough JW, Charney DS. A Randomized Controlled Trial of Repeated Ketamine Administration for Chronic Posttraumatic Stress Disorder. Am J Psychiatry. 2021 Feb 1;178(2):193-202. doi: 10.1176/appi.ajp.2020.20050596. Epub 2021 Jan 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Feder, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine and Midazolam in people with Posttraumatic Stress Disorder (PTSD), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: 2 weeks after the first infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02397889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.