DeliriumPhase 3NCT00599287
Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients
A Phase 3 study testing Haloperidol, Methylphenidate and Rivastigmine in people with Delirium, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled, doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or haloperidol in hypoactive ICU-delirium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Haloperidol, Methylphenidate and Rivastigmine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2008to May 2008
- Phase
- Phase 3
- 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
- Older than 18 years
- Diagnosed as hypoactive delirium
- Informed consent given
Who cannot join
- Pregnancy
- Epilepsy
- M. Parkinson
- Lewy-body dementia
- Prolonged QT-time
- Known allergy to the medicinals used
Show all 13Show fewer
- Renal replacement therapy
- Hepatic encephalopathy
- Hyperthyroid
- Glaucoma
- Previous suicide attempts
- Syndrome of Gilles de la Tourette
- Patients which cannot receive the medication oral or through a nasogastric tube
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-blind Pilot Trial
The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled, doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or haloperidol in hypoactive ICU-delirium. In addition we will compare duration of delirium, severity of delirium, length of ICU/hospital stay and side effects between the different interventions.
- Conditions
- Delirium
- Being tested
- Haloperidol, Methylphenidate, Rivastigmine
- Keywords
- ICU delirium, Hypoactive delirium, Haloperidol, Methylphenidate, Rivastigmine, Hypoactive ICU delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
Also called Haldol
Haloperidol 2,5 mg. 2 dd 1, oral. (if patient is 69 years or younger) Haloperidol 1 mg. 2 dd 1, oral (if patient is 70 years or older)
MethylphenidateDrug
Also called Ritalin
Methylphenidate 5 mg. 2 dd 1, oral, increased every day with 10 mg. until negative CAM(-ICU) or side-effects. Maximum dosage 30 mg./day
RivastigmineDrug
Also called Exelon
Rivastigmine 1,5 mg. 2 dd 1, oral, increased every third day with 3 mg. until negative CAM(-ICU) or side-effects. Maximum dosage 12 mg./day
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | No intervention |
| 2 | Experimental | Methylphenidate Receives: Drug: Methylphenidate |
| 3 | Experimental | Rivastigmine Receives: Drug: Rivastigmine |
| 4 | Experimental | Haloperidol Receives: Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of delirium
Measured: Days
Secondary outcomes (4)
duration of ICU-stay
Measured: days
duration of in hospital stay
Measured: days
delirium severity
Measured: duration of delirium
frequency of side effects
Measured: duration of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Jozef Kesecioglu, MD PhD, Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599287
- Sponsor's protocol ID
- ICHYPDEL/002
- Other IDs
- METC-UMCU 07/236
- Status last verified
- Feb 2008
- First submitted
- 10 Jan 2008
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-blind Pilot Trial
- ClinicalTrials.gov ID
- NCT00599287
- Acronym / sponsor ID
- ICHYPDEL/002
- Conditions
- Delirium
- Keywords
- ICU delirium, Hypoactive delirium, Haloperidol, Methylphenidate, Rivastigmine, Hypoactive ICU delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 23 Jan 2008 (estimated)
- 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.
The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled, doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or haloperidol in hypoactive ICU-delirium. In addition we will compare duration of delirium, severity of delirium, length of ICU/hospital stay and side effects between the different interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –No intervention |
| 2 | Experimental | Drug: MethylphenidateMethylphenidate |
| 3 | Experimental | Drug: RivastigmineRivastigmine |
| 4 | Experimental | Drug: HaloperidolHaloperidol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years
- Diagnosed as hypoactive delirium
- Informed consent given
Key exclusion criteria (13 listed)
- Pregnancy
- Epilepsy
- M. Parkinson
- Lewy-body dementia
- Prolonged QT-time
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 |
|---|---|---|
| HaloperidolAlso: HaldolHaloperidol 2,5 mg. 2 dd 1, oral. (if patient is 69 years or younger) Haloperidol 1 mg. 2 dd 1, oral (if patient is 70 years or older) | Drug | 4 |
| MethylphenidateAlso: RitalinMethylphenidate 5 mg. 2 dd 1, oral, increased every day with 10 mg. until negative CAM(-ICU) or side-effects. Maximum dosage 30 mg./day | Drug | 2 |
| RivastigmineAlso: ExelonRivastigmine 1,5 mg. 2 dd 1, oral, increased every third day with 3 mg. until negative CAM(-ICU) or side-effects. Maximum dosage 12 mg./day | Drug | 3 |
Primary outcome
duration of delirium
Time frame: Days
4 secondary outcomes
duration of ICU-stay
Time frame: days
duration of in hospital stay
Time frame: days
delirium severity
Time frame: duration of delirium
frequency of side effects
Time frame: duration of intervention
Results and safety
The study was stopped early (reason given: Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Jozef Kesecioglu, MD PhD study director
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Haloperidol, Methylphenidate and Rivastigmine in people with Delirium, run by UMC Utrecht at 1 site in Netherlands.
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 3 inclusion and 13 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 21 Mar 2018. 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 Netherlands. 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 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?
The study was stopped early (reason given: Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.). Results are not available in the source record.
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?
duration of delirium (time frame: Days). 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 21 Mar 2018.