Suicide Crisis SyndromePhase 4NCT06133114
Psychopharmacological Treatment of Emotional Distress
A Phase 4 study testing Clonazepam, Olanzapine and Buprenorphine in people with Suicide Crisis Syndrome and Psychological Distress, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with treatment as usual (TAU arm) in the treatment of emotional distress, specifically the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Crisis Syndrome, Psychological Distress
- What is being tested?
- Clonazepam, Olanzapine and Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2024to 13 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient admitted to an inpatient unit and ruled in for SCS diagnosis using SCS-C
- Willing to stay in the hospital voluntarily, if medically necessary, for at least 4 days after enrolling in the study.
- Patient admitted to an inpatient unit as a result of a recent (i.e., past-month) suicide attempt, as defined by the C-SSRS (Columbia Suicide Rating Scale).
- Admitted to an inpatient unit in the last 36 hrs.
- Able to understand the nature and the substance of the consent form.
- Currently domiciled.
- Able and willing to provide verifiable contact information for follow-up.
Who cannot join
- Intellectual disability, cognitive impairment, or linguistic limitation precluding understanding of the consent or research questions.
- Past adverse reactions to clonazepam, olanzapine, or buprenorphine
- Past history of opiate or benzodiazepine use d/o in the last 2 years
- On agonist therapy for opiate addiction
- Ongoing treatment with clonazepam or olanzapine.
- Significant medical or neurological disease or possible delirium that might interfere with study participation or capacity to provide informed consent.
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- Receiving involuntary treatment in psychiatric unit
- Clinical suspicion of malingering by a CP.
- Undomiciled.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial
This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with treatment as usual (TAU arm) in the treatment of emotional distress, specifically the Suicide Crisis Syndrome (SCS). All participants in experimental arms receive 2-day pulse treatments targeting four out of five of the acute emotional distress symptoms. The primary outcome measure is SCS at discharge and one-month follow-up. The secondary outcome measures include questions about suicidal behaviors associated with emotional distress at a one-month follow-up.
- Conditions
- Suicide Crisis Syndrome, Psychological Distress
- Being tested
- Clonazepam, Olanzapine, Buprenorphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonazepamDrug
Also called TAU
0.5 mg twice a day (1 mg a day)
OlanzapineDrug
2.5 mg once a day of Olanzapine
BuprenorphineDrug
2 mg once a day of Buprenorphine
| Study group | Role | What they receive |
|---|---|---|
| S arm: Single drug clonazepam | Experimental | Single drug clonazepam: 1 mg a day (0.5 mg twice a day) with Treatment As Usual (TAU) Receives: Drug: Clonazepam |
| D arm: Two-drug combination clonazepam/olanzapine | Experimental | Two-drug combination clonazepam/olanzapine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine with Treatment As Usual (TAU) Receives: Drug: Clonazepam; Drug: Olanzapine |
| T arm: Three-drug combination clonazepam/olanzapine/buprenorphine | Experimental | Three-drug combination clonazepam/olanzapine/buprenorphine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine plus 2mg a day of Buprenorphine with Treatment As Usual (TAU) Receives: Drug: Clonazepam; Drug: Olanzapine; Drug: Buprenorphine |
| Control Group | No intervention | Participants that will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Crisis Syndrome-Checklist (SCS-C)
The SCS-C is a clinician rated measure assessing clinicians' assessment of the presence and intensity of the Suicide Crisis Syndrome among their patients. The SCS-C includes 13 dichotomous items reflecting the presence or absence of the SCS symptoms. The SCS-C also assesses the presence of the five SCS criteria (entrapment, affective disturbances, loss of cognitive control, hyperarousal and social withdrawal). The first item is a clinician rating of entrapment (SCS criterion A), rated as yes or no. The second item assesses the 4 domains of SCS criterion B: affective disturbance, loss of cognitive control, hyperarousal, and social withdrawal.
This item is rated yes if the patient exhibits 1 of the domains. A final rating is recorded as positive if both criteria A and B are rated as yes. A positive rating in the final rating reflects a positive SCS diagnosis.
Measured: up to 1 month follow up after discharge
Secondary outcomes (1)
Suicide Crisis Inventory-Short Form (SCI-SF) for Severity
The SCI-SF is an 8-item version of the original 49-item Suicide Crisis Inventory that assesses the severity of different cognitive and affective states theorized in the SCS. Patients rate how they feel on a 5-point scale ranging from 0 (not at all) to 4 (extremely), with higher scores indicating more severe symptoms.
Measured: up to 1 month follow up after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start13 Mar 2024
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Why it stopped: Enrollment was discontinued after limited accrual prevented feasible completion of the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide Crisis SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Galynker, Icahn School of Medicine at Mount Sinai
- Investigators
- Igor Galynker, MD,PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133114
- Sponsor's protocol ID
- STUDY-22-01296
- Status last verified
- Jul 2026
- First submitted
- 10 Nov 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. Results will be published by the investigator in individual journals.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06133114
- Acronym / sponsor ID
- STUDY-22-01296
- Conditions
- Suicide Crisis Syndrome, Psychological Distress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment was discontinued after limited accrual prevented feasible completion of the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with treatment as usual (TAU arm) in the treatment of emotional distress, specifically the Suicide Crisis Syndrome (SCS). All participants in experimental arms receive 2-day pulse treatments targeting four out of five of the acute emotional distress symptoms. The primary outcome measure is SCS at discharge and one-month follow-up. The secondary outcome measures include questions about suicidal behaviors associated with emotional distress at a one-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S arm: Single drug clonazepam | Experimental | Drug: ClonazepamSingle drug clonazepam: 1 mg a day (0.5 mg twice a day) with Treatment As Usual (TAU) |
| D arm: Two-drug combination clonazepam/olanzapine | Experimental | Drug: Clonazepam, Drug: OlanzapineTwo-drug combination clonazepam/olanzapine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine with Treatment As Usual (TAU) |
| T arm: Three-drug combination clonazepam/olanzapine/buprenorphine | Experimental | Drug: Clonazepam, Drug: Olanzapine, Drug: BuprenorphineThree-drug combination clonazepam/olanzapine/buprenorphine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine plus 2mg a day of Buprenorphine with Treatment As Usual (TAU) |
| Control Group | No intervention | –Participants that will not receive an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient admitted to an inpatient unit and ruled in for SCS diagnosis using SCS-C
- Willing to stay in the hospital voluntarily, if medically necessary, for at least 4 days after enrolling in the study.
- Patient admitted to an inpatient unit as a result of a recent (i.e., past-month) suicide attempt, as defined by the C-SSRS (Columbia Suicide Rating Scale).
- Admitted to an inpatient unit in the last 36 hrs.
- Able to understand the nature and the substance of the consent form.
Key exclusion criteria (9 listed)
- Intellectual disability, cognitive impairment, or linguistic limitation precluding understanding of the consent or research questions.
- Past adverse reactions to clonazepam, olanzapine, or buprenorphine
- Past history of opiate or benzodiazepine use d/o in the last 2 years
- On agonist therapy for opiate addiction
- Ongoing treatment with clonazepam or olanzapine.
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 |
|---|---|---|
| ClonazepamAlso: TAU0.5 mg twice a day (1 mg a day) | Drug | D arm: Two-drug combination clonazepam/olanzapine, S arm: Single drug clonazepam, T arm: Three-drug combination clonazepam/olanzapine/buprenorphine |
| Olanzapine2.5 mg once a day of Olanzapine | Drug | D arm: Two-drug combination clonazepam/olanzapine, T arm: Three-drug combination clonazepam/olanzapine/buprenorphine |
| Buprenorphine2 mg once a day of Buprenorphine | Drug | T arm: Three-drug combination clonazepam/olanzapine/buprenorphine |
Primary outcome
Suicide Crisis Syndrome-Checklist (SCS-C)
Time frame: up to 1 month follow up after discharge
The SCS-C is a clinician rated measure assessing clinicians' assessment of the presence and intensity of the Suicide Crisis Syndrome among their patients. The SCS-C includes 13 dichotomous items reflecting the presence or absence of the SCS symptoms. The SCS-C also assesses the presence of the five SCS criteria (entrapment, affective disturbances, loss of cognitive control, hyperarousal and social withdrawal). The first item is a clinician rating of entrapment (SCS criterion A), rated as yes or no. The second item assesses the 4 domains of SCS criterion B: affective disturbance, loss of cognitive control, hyperarousal, and social withdrawal. This item is rated yes if the patient exhibits 1 of the domains. A final rating is recorded as positive if both criteria A and B are rated as yes. A positive rating in the final rating reflects a positive SCS diagnosis.
1 secondary outcome
Suicide Crisis Inventory-Short Form (SCI-SF) for Severity
Time frame: up to 1 month follow up after discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Results will be published by the investigator in individual journals.
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.
Igor Galynker, MD,PhD 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 4 study testing Clonazepam, Olanzapine and Buprenorphine in people with Suicide Crisis Syndrome and Psychological Distress, 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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 28 Jul 2026. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Suicide Crisis Syndrome-Checklist (SCS-C) (time frame: up to 1 month follow up after discharge). 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 28 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.