Psychiatric EmergencyPhase 4TRECNCT03639558

TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting

A Phase 4 study testing Haloperidol + Promethazine + Chlorpromazine and Haloperidol + Promethazine in people with Psychiatric Emergency and Aggression, run by Joseph Dib at 2 sites in Lebanon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Psychiatric Emergency, Aggression, Agitation
What is being tested?: Haloperidol + Promethazine + Chlorpromazine and Haloperidol + Promethazine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesLebanon
Study dates: 28 Aug 2018to 7 Jul 2019
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
Healthy volunteers accepted
Adult

Who may be able to join

Patient will be eligible if (1) requiring emergency acute intramuscular sedation because of disturbed and dangerous behaviour and (2) if the clinician is uncertain of the benefits between haloperidol plus promethazine vs haloperidol plus promethazine plus chlorpromazine.
Gender - both male and female
Age (18-64)
Clinician is unaware on the effects of either treatment interventions

Who cannot join

If the clinician KNOWS one treatment has benefit over another for a particular person
If the clinician is aware of a contra-indication of one of the treatments
If there is an Advanced Directive expressing a wish for one or other, or another treatment in the emergency setting.
If the clinician does not want to undertake for both personal and professional reasons.
If the participant is known to be allergic to one or more of the interventions
Already randomized
Already sedated
Accompanying person (Friend/Family/Police Officer) refuses patient trial entry

Trial locations and contacts

2 sites in 1 country.

Lebanon2 sites

Hôpital Psychiatrique De La Croix
Beirut, Jal L Dib
Psychiatric Hospital of the Cross
Beirut

Other trials in Lebanon

About this study

Official title: TREC-Lebanon Trial: A Randomised Controlled Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting

This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.

Read the detailed description

This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department. Around 10% of patients will present to the psychiatric emergency unit with a violent episode that requires rapid tranquilisation. Surveys of practice and opinion has shown that variety of methods have been used and no universal option exists. This study will look at Haloperidol plus promethazine versus haloperidol plus promethazine plus chlorpromazine in violent aggressive psychiatric patients.

Conditions: Psychiatric Emergency, Aggression, Agitation
Being tested: Haloperidol + Promethazine + Chlorpromazine, Haloperidol + Promethazine
Medical subject headings: Aggression, Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Haloperidol + Promethazine + ChlorpromazineDrug
Also called HPC
This is the usual treatment given by this hospital during an aggressive psychiatric episode.
Haloperidol + PromethazineDrug
Also called HP
This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.

Study groups in NCT03639558
Study group	Role	What they receive
Haloperidol + Promethazine + Chlorpromazine	Active comparator	Haloperidol + Promethazine + Chlorpromazine are all psychiatric drugs that have been well tested. The combination of these 3 drugs, however, have never been randomised. Receives: Drug: Haloperidol + Promethazine + Chlorpromazine
Haloperidol + Promethazine	Experimental	Haloperidol + Promethazine are both psychiatric drugs with antipsychotic and calming properties. Receives: Drug: Haloperidol + Promethazine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil
Patient no longer exhibiting aggressive behavior both verbal and physical post intervention treatment. A primary measure of outcome form will contain a Calm or Tranquil column followed by four rows: 20 mins, 40 mins, 60 mins and 120 mins post intervention medication. The boxes would be ticked depending if the patient meets the primary measure of outcome within the time frame provided.
Measured: 20, 40, 60 and 120 minutes post intervention treatment

Secondary outcomes (4)

Time Taken for Patient to Fall Asleep Post Intervention
Patient has fallen asleep and is no longer aggressive post intervention treatment and will be noted on the outcomes form which includes a checklist of different time intervals: 20, 40, 60 and 120 minutes post intervention treatment.
Measured: 20, 40, 60 and 120 minutes post intervention treatment
Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment
If patient was placed in a straitjacket post intervention due to aggression - this would be noted on the outcomes form which includes a checklist at certain time intervals 20,40,60 and 120 minutes post intervention treatment.
Measured: 20, 40, 60 and 120 minutes post intervention treatment
Time Noted Where Important Adverse Effects Occurred Post Intervention
If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames.
Measured: 20, 40, 60 and 120 minutes post intervention treatment
Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered.
If patient had to leave ward against medical advice during intervention phase - the time will be noted as well as the reason to why patient left.
Measured: 20, 40, 60 and 120 minutes post intervention treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 20187 Jul 2019

First posted21 Aug 2018
Study start28 Aug 2018
Primary completion1 Jul 2019
Study completion7 Jul 2019

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 Psychiatric EmergencyStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03639558
Sponsor's protocol ID: DPAP - 2018 - 0138 - 1
Acronym: TREC
Status last verified: Jun 2022
First submitted: 15 Aug 2018
Last updated: 14 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Dib JE, Adams CE, Ikdais WH, Atallah E, Yaacoub HE, Merheb TJ, Kazour F, Tahan F, Haddad G, Zoghbi M, Azar J, Haddad C, Hallit S. Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon). F1000Res. 2019 Aug 15;8:1442. doi: 10.12688/f1000research.19933.1. eCollection 2019.
PubMed 32528650

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Psychiatric Emergency trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TREC-Lebanon Trial: A Randomised Controlled Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
ClinicalTrials.gov ID: NCT03639558
Acronym / sponsor ID: TREC / DPAP - 2018 - 0138 - 1
Conditions: Psychiatric Emergency, Aggression, Agitation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Joseph DibOther government
Collaborators: University of Nottingham, Hopital Psychiatrique De La Croix
Study start: 28 Aug 2018 (actual)
Primary completion: 1 Jul 2019 (actual)
Study completion: 7 Jul 2019 (actual)
First posted: 21 Aug 2018 (actual)
Results: Posted 14 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Haloperidol + Promethazine + Chlorpromazine	Active comparator	Drug: Haloperidol + Promethazine + ChlorpromazineHaloperidol + Promethazine + Chlorpromazine are all psychiatric drugs that have been well tested. The combination of these 3 drugs, however, have never been randomised.
Haloperidol + Promethazine	Experimental	Drug: Haloperidol + PromethazineHaloperidol + Promethazine are both psychiatric drugs with antipsychotic and calming properties.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patient will be eligible if (1) requiring emergency acute intramuscular sedation because of disturbed and dangerous behaviour and (2) if the clinician is uncertain of the benefits between haloperidol plus promethazine vs haloperidol plus promethazine plus chlorpromazine.
Gender - both male and female
Age (18-64)
Clinician is unaware on the effects of either treatment interventions

Key exclusion criteria (8 listed)

If the clinician KNOWS one treatment has benefit over another for a particular person
If the clinician is aware of a contra-indication of one of the treatments
If there is an Advanced Directive expressing a wish for one or other, or another treatment in the emergency setting.
If the clinician does not want to undertake for both personal and professional reasons.
If the participant is known to be allergic to one or more of the interventions

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
Haloperidol + Promethazine + ChlorpromazineAlso: HPCThis is the usual treatment given by this hospital during an aggressive psychiatric episode.	Drug	Haloperidol + Promethazine + Chlorpromazine
Haloperidol + PromethazineAlso: HPThis is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.	Drug	Haloperidol + Promethazine

Primary outcome

Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil
Time frame: 20, 40, 60 and 120 minutes post intervention treatment
Patient no longer exhibiting aggressive behavior both verbal and physical post intervention treatment. A primary measure of outcome form will contain a Calm or Tranquil column followed by four rows: 20 mins, 40 mins, 60 mins and 120 mins post intervention medication. The boxes would be ticked depending if the patient meets the primary measure of outcome within the time frame provided.

4 secondary outcomes

Time Taken for Patient to Fall Asleep Post Intervention
Time frame: 20, 40, 60 and 120 minutes post intervention treatment
Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment
Time frame: 20, 40, 60 and 120 minutes post intervention treatment
Time Noted Where Important Adverse Effects Occurred Post Intervention
Time frame: 20, 40, 60 and 120 minutes post intervention treatment
Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered.
Time frame: 20, 40, 60 and 120 minutes post intervention treatment

Results and safety

Results posted to the registry on 14 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Haloperidol + Promethazine + Chlorpromazine	52	51
Haloperidol + Promethazine	48	43

Primary outcome: Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil

Time frame: 20, 40, 60 and 120 minutes post intervention treatment. Number. Unit: participants

Measure	Haloperidol + Promethazine + Chlorpromazine n = 52	Haloperidol + Promethazine n = 48
Calm or tranquil at 20 minutes	18	14
Calm or tranquil at 40 minutes	41	25
Calm or tranquil at 60 minutes	45	35
Calm or tranquil at 120 minutes	47	35

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 months from time of intervention.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Haloperidol + Promethazine + Chlorpromazine	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Haloperidol + Promethazine	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Limitations and caveats (from the sponsor): Possible limitations for this trial are that there are no Emergency Departments; therefore residents must always carry the TREC envelopes at all times, increasing the risk for error (i.e. misplacing envelope, using wrong envelope, etc.). Despite the limitation, the chances of error remain low due to the small sample size of 100.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32528650Dib JE, Adams CE, Ikdais WH, Atallah E, Yaacoub HE, Merheb TJ, Kazour F, Tahan F, Haddad G, Zoghbi M, Azar J, Haddad C, Hallit S. Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon). F1000Res. 2019 Aug 15;8:1442. doi: 10.12688/f1000research.19933.1. eCollection 2019.
Individual participant dataSharing planned: No

Related trials for Psychiatric Emergency

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Assessment of the Preventive Effect of Defusing on Traumatic Kindling
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Haloperidol + Promethazine + Chlorpromazine and Haloperidol + Promethazine in people with Psychiatric Emergency and Aggression, run by Joseph Dib at 2 sites in Lebanon.

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 4 inclusion and 8 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 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Lebanon. 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?

Yes. Results are posted in the registry (first posted 14 Jun 2022). 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?

Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil (time frame: 20, 40, 60 and 120 minutes post intervention treatment). 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 NCT03639558, 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 14 Jun 2022.