Suicidal IdeationPhase 4NCT02997722
The Effect of Ketamine on the Length of Hospital Stay of Patients Hospitalized With Suicidal Ideation.
A Phase 4 study testing Ketamine and Normal Saline in people with Suicidal Ideation, run by Allen Richert at 1 site in United States.
Trial summary
This study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein. The other half will receive a placebo. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Ketamine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2017to 19 May 2017
- Phase
- Phase 4
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women between the ages of 18 and 64
- Patients admitted to the University of Mississippi Medical Center inpatient psychiatry service with suicidal ideations
Who cannot join
- Lifetime history of schizophrenia or other primary psychotic disorder
- Current psychotic or manic symptoms
- Substance use disorder within one month of admission
- Positive urine toxicology at admission
- Any lifetime abuse of ketamine or phencyclidine
- Systolic BP >180 mmHg or diastolic BP >110 mmHg
Show all 17Show fewer
- Any patient who has eaten food within 8 hours prior to receiving the ketamine infusion or who has drank clear liquids within 2 hours prior to receiving the infusion
- Known central nervous system (CNS) mass
- CNS abnormalities
- Hydrocephalus
- Glaucoma
- Acute globe injury
- Porphyria
- Untreated thyroid disease
- Known coronary artery disease with poor functional capacity
- Pregnancy
- Currently breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Ketamine: Its Effects on Suicidal Ideations and Inpatient Hospital Length of Stay
This study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein. The other half will receive a placebo. Because we think that ketamine will improve depression and suicidal thoughts, we expect that patients who receive ketamine will require less time in the hospital than patients who receive placebo.
Read the detailed description
Patients admitted to UMMC's psychiatry inpatient unit with suicidal thoughts will be given the opportunity to participate in the study. Those patients who consent to participate, after being informed about the study and its risks, will be randomized to receive an IV infusion of either saline or ketamine 0.5 mg/kg. The infusion will be given within 24 hours of arriving on the psychiatry inpatient unit. We will record the dates and times that the patient was admitted to and discharged from the psychiatric inpatient unit. At completion of the study, we will compare the average length of stay, defined as date and time of discharge minus date of time of admission, of the group that received ketamine to the average length of stay of the group that received placebo.
- Conditions
- Suicidal Ideation
- Being tested
- Ketamine, Normal Saline
- Keywords
- ketamine, suicidal ideation, length of stay
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
Normal SalineDrug
IV infusion of 100 ml of normal saline over 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine infusion | Experimental | Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes. Receives: Drug: Ketamine |
| Normal Saline infusion | Placebo comparator | Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient Hospital Length of Stay
We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.
Measured: The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start2 Mar 2017
- Primary completion19 May 2017
- Study completion19 May 2017
Why it stopped: Staffing and space deficiencies prevented completion of the study.
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.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allen Richert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Allen Richert, University of Mississippi Medical Center
- Investigators
- Allen C Richert, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997722
- Sponsor's protocol ID
- 2016-0107
- Status last verified
- May 2020
- First submitted
- 15 Dec 2016
- Last updated
- 2 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine: Its Effects on Suicidal Ideations and Inpatient Hospital Length of Stay
- ClinicalTrials.gov ID
- NCT02997722
- Acronym / sponsor ID
- 2016-0107
- Conditions
- Suicidal Ideation
- Keywords
- ketamine, suicidal ideation, length of stay
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staffing and space deficiencies prevented completion of the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Allen RichertUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein. The other half will receive a placebo. Because we think that ketamine will improve depression and suicidal thoughts, we expect that patients who receive ketamine will require less time in the hospital than patients who receive placebo.
Detailed description
Patients admitted to UMMC's psychiatry inpatient unit with suicidal thoughts will be given the opportunity to participate in the study. Those patients who consent to participate, after being informed about the study and its risks, will be randomized to receive an IV infusion of either saline or ketamine 0.5 mg/kg. The infusion will be given within 24 hours of arriving on the psychiatry inpatient unit. We will record the dates and times that the patient was admitted to and discharged from the psychiatric inpatient unit. At completion of the study, we will compare the average length of stay, defined as date and time of discharge minus date of time of admission, of the group that received ketamine to the average length of stay of the group that received placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine infusion | Experimental | Drug: KetamineAssignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes. |
| Normal Saline infusion | Placebo comparator | Drug: Normal SalineAssignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women between the ages of 18 and 64
- Patients admitted to the University of Mississippi Medical Center inpatient psychiatry service with suicidal ideations
Key exclusion criteria (17 listed)
- Lifetime history of schizophrenia or other primary psychotic disorder
- Current psychotic or manic symptoms
- Substance use disorder within one month of admission
- Positive urine toxicology at admission
- Any lifetime abuse of ketamine or phencyclidine
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 |
|---|---|---|
| KetamineIV infusion of ketamine 0.5 mg/kg administered over 45 minutes. | Drug | Ketamine infusion |
| Normal SalineIV infusion of 100 ml of normal saline over 45 minutes. | Drug | Normal Saline infusion |
Primary outcome
Inpatient Hospital Length of Stay
Time frame: The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.
We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Allen C Richert, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Normal Saline in people with Suicidal Ideation, run by Allen Richert 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 2 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: stopped early, as of the sponsor's last update on 2 Jun 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 29 Apr 2020). 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?
Inpatient Hospital Length of Stay (time frame: The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2020.