Suicidal IdeationPhase 2ASPIREDNCT07868913
Alleviating Suicidality by Combining Psychotherapy and IM Ketamine for Rapid Treatment in the Emergency Department
A Phase 2 study testing Ketamine Injectable Solution, Crisis Response Plan and Safety Planning in people with Suicidal Ideation, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
Participants are asked to take part in this research study after coming to the Emergency Department with thoughts or behaviors of seriously hurting themselves. There are very few resources to treat acute suicidal thoughts or behaviors in an emergency department. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Ketamine Injectable Solution, Crisis Response Plan and Safety Planning
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2026to 30 Sep 2028
- Phase
- Phase 2
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation anticipated to be admitted as an inpatient at University Health (UH) or Carl R Darnall Army Medical Center (CRDAMC) based on the ED and admitting providers determination that the patient warrants hospitalization for suicidality and the capacity of the institution to admit the patient.
- Able to read and write English.
Who cannot join
- Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms determined to be the priority of treatment relative to treatment of the suicidal thoughts and behaviors.
- Acute intoxication with clinically significant symptoms as determined by the ED provider to significantly increase the risk of participation (e.g., potential interaction with ketamine) or render the patient unable to consent.
- The patient is not capable of understanding the research procedures and providing informed consent for themselves as determined by the research staff obtaining informed consent in consultation with the patient's ED provider.
- Admittance to and treatment in an ED for acute suicidality within the past 30 days as determined by self-report, or if available, hospital records.
- Lack of reliable means to be available for follow-up assessments (e. g, working mobile phone) as determined by self-report.
- Persistent resting blood pressure lower than 90/60 or higher than 180/110, or persistent resting heart rate lower than 45 beats/minute or higher than 120 beats/minute.
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- Injuries requiring procedural sedation with ketamine as determined by the patient's ED provider.
- Pregnancy as determined by pregnancy testing, or self-report of breast feeding.
- Known hypersensitivity to ketamine as determined by self-report.
- Legal or illegal use of ketamine in the previous 90 days as determined by self-report.
- End-stage or severe cardiovascular (e.g., acute coronary syndrome (ACS) or decompensated heart failure), end-stage or severe liver, or kidney disease as determined by the ED chart history and ED provider's exam.
- Patient is a prisoner as determined by prisoner escort.
- Patient is physically restrained or actively under custody of law enforcement.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Carl R Darnall Army Medical Center (CRDAMC)
Fort Hood, Texas, 76544
Kevin Schlicksup, MD, MEd
- Recruiting
University Hospital (UH)
San Antonio, Texas, 78229
Robert DeLorenzo, MD, 210 567-4292, delorenzo@uthscsa.edu
Stephanie Martinez, MHA, 210 450-8566, martinezs13@uthscsa.edu
About this study
Official title: ASPIRED: Alleviating Suicidality by Combining Psychotherapy and IM Ketamine for Rapid Treatment in the Emergency Department - A Randomized Clinical Trial.
Participants are asked to take part in this research study after coming to the Emergency Department with thoughts or behaviors of seriously hurting themselves. There are very few resources to treat acute suicidal thoughts or behaviors in an emergency department. The purpose of this study is to evaluate the effectiveness of combining an intramuscular (IM) injection of ketamine and Crisis Response Planning (CRP), a single, 45-60 minute psychological intervention with a therapist, to quickly reduce suicidal thoughts in patients treated in an emergency department (ED) prior to being admitted to the hospital.
Read the detailed description
Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation requiring and anticipated to be for admitted as an inpatient to UH or CRDAMC based on the ED and admitting providers determination that the patient warrants hospitalization for suicidality and the capacity of the institution to admit the patient will be identified by an ED staff member.
Following consent, participants will complete the baseline assessment at the hospital in the patient's assigned room. Once confirmed eligible, the participant will be randomly assigned into one of the four study arms.
The study injection (either the ketamine (1 mg/kg) or saline placebo (volume matched to the equivalent dose of ketamine) for injection) will be administered in the ED by Nursing staff and the CRP will be administered by a trained member of the research team. Participants randomized to the safety plan control condition will receive their plan from hospital staff at discharge from the hospital as standard of care.
Following the study injection, the ED clinical staff are responsible for monitoring participants for one hour for common side effects of ketamine including symptoms of dizziness, nausea, vomiting, confusion, or dissociative episodes. Patients' vital signs and pulse oximetry will also be monitored in accordance with the facility ED protocol for sub-dissociative administration of ketamine (e.g. frequent vital signs for 45 minutes).
Follow-up assessments will be completed at 24-hours, 48-hours, 72-hours, 7-days, 28-days, and 56-days after study treatment in the STRONG STAR offices, or by phone.
- Conditions
- Suicidal Ideation
- Being tested
- Ketamine Injectable Solution, Placebo Injection, Crisis Response Plan, Safety Planning
- Keywords
- Psychotherapy, Crisis Response Planning, Intramuscular ketamine, Emergency department
- Medical subject headings
- Suicidal Ideation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Injectable SolutionDrug
Also called Ketamine Intramuscular (IM) Injection
1 mg.kg IM ketamine is administered after enrollment and randomization
Placebo InjectionOther
Also called Sodium Chloride Solution 0.9%
Placebo is administered after enrollment and randomization
Crisis Response PlanBehavioural
Also called CRP
Crisis Response Planning is a collaborative, patient-centered psychosocial intervention that begins with a narrative assessment and concludes with the development of a personalized plan that outlines a series of self-regulatory strategies for managing acute emotional distress
Safety PlanningOther
Also called Safety Plan Control
The Safety Planning intervention (provided as standard of care at discharge) includes a brief review of current suicide risk, provides patients with a suite of cognitive tools for avoiding future acute crises, and allows for a discussion and teach-back period to ensure patients' understanding of and willingness to use the plan
| Study group | Role | What they receive |
|---|---|---|
| Ketamine plus CRP | Experimental | Ketamine is administered and Crisis Response Planning developed for participants Receives: Drug: Ketamine Injectable Solution; Behavioral: Crisis Response Plan |
| Ketamine plus Safety plan control | Experimental | Ketamine is administered and the Safety plan control administered as standard of care at discharge Receives: Drug: Ketamine Injectable Solution; Other: Safety Planning |
| Placebo plus CRP | Experimental | Placebo is administered and Crisis Response Planning developed for participants Receives: Other: Placebo Injection; Behavioral: Crisis Response Plan |
| Placebo plus Safety plan control | Placebo comparator | Placebo is administered and the Safety plan control administered as standard of care at discharge Receives: Other: Placebo Injection; Other: Safety Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms Index - Suicidality Subscale (DSI-SS)
A 4 item scale scored from 0-3 for each item and summed to give a total between 0-12 with a higher score indication greater suicidal ideation.
Measured: Baseline, 24 hours and 28 days
Secondary outcomes (2)
Suicide Visual Analogue Scale (S-VAS)
A scale scored from 0=none to 100=extreme urge to commit suicide
Measured: Baseline to 56 days
Beck Scale for Suicidal Ideation (SSI)
A scale with 19 possible items scored from 0-2 to give a possible score between 0-38 with a higher score indicating greater suicidal ideation. If the participant scores 0 (no indication of suicidal ideation) on questions 4 and 5, the survey is stopped at that point, otherwise the survey is continued.
Measured: Baseline to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a four-arm 2x2 factorial design randomized clinical trial (RCT)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Robert DeLorenzo, The University of Texas Health Science Center at San Antonio
- Investigators
- Robert DeLorenzo, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868913
- Sponsor's protocol ID
- STUDY00002358
- Other IDs
- HT9425-24-1-0519
- Acronym
- ASPIRED
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will follow institutional policies regarding presentations and publications and the International Committee of Medical Journal Editors (ICMJE) "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals"