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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: Haloperidol
  • 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)
• Drug: Methylphenidate
  • 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
• Drug: Rivastigmine
  • 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
• Other: No intervention
  • No intervention

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • No intervention
• Experimental: 2
  • Methylphenidate
• Experimental: 3
  • Rivastigmine
• Experimental: 4
  • Haloperidol

Primary Measures

• duration of delirium
  • Time Frame: Days
    Safety Issue?: No

Secondary Measures

• duration of ICU-stay
  • Time Frame: days
    Safety Issue?: No
• duration of in hospital stay
  • Time Frame: days
    Safety Issue?: No
• delirium severity
  • Time Frame: duration of delirium
    Safety Issue?: No
• frequency of side effects
  • Time Frame: duration of intervention
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UMC Utrecht

Overall Clinical Trial Officials and Contacts

Jozef Kesecioglu, MD PhD Study Director University Medical Center Utrecht  

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00599287

Study ID Number: ICHYPDEL/002

ClinicalTrials.gov Identifier: NCT00599287

Health Authority: Netherlands: Medical Ethics Review Committee (METC)