Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients

Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-blind Pilot Trial

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00599287

Enrollment

Registered

2008-01-23

Start date

2008-02-29

Completion date

2008-05-31

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

ICU delirium, Hypoactive delirium, Haloperidol, Methylphenidate, Rivastigmine, Hypoactive ICU delirium

Brief 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. In addition we will compare duration of delirium, severity of delirium, length of ICU/hospital stay and side effects between the different interventions.

Interventions

DRUGHaloperidol

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)

DRUGMethylphenidate

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

DRUGRivastigmine

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Older than 18 years * Diagnosed as hypoactive delirium * Informed consent given

Exclusion criteria

* Pregnancy * Epilepsy * M. Parkinson * Lewy-body dementia * Prolonged QT-time * Known allergy to the medicinals used * 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

Design outcomes

Primary

Measure	Time frame
duration of delirium	Days

Secondary

Measure	Time frame
duration of ICU-stay	days
duration of in hospital stay	days
delirium severity	duration of delirium
frequency of side effects	duration of intervention

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026