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

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 Overview

• Status: Terminated
• Conditions: Delirium
• Intervention / Treatment: Drug: Methylphenidate; Drug: Rivastigmine; Drug: Haloperidol

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3508 GA
    • University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1; No intervention
Experimental: 2; Methylphenidate	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; Other Names: Ritalin
Experimental: 3; Rivastigmine	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 Names: Exelon
Experimental: 4; Haloperidol	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); Other Names: Haldol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
duration of delirium	Days

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Study Director: Jozef Kesecioglu, MD PhD, UMC Utrecht

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: January 10, 2008
• First Submitted That Met QC Criteria: January 22, 2008
• First Posted (Estimate): January 23, 2008

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: Rivastigmine; Methylphenidate; Haloperidol; ICU delirium; Hypoactive delirium; Hypoactive ICU delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Delirium; Hypokinesia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Antiemetics; Gastrointestinal Agents; Neuroprotective Agents; Protective Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Antagonists; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Anti-Dyskinesia Agents; Cholinesterase Inhibitors; Methylphenidate; Haloperidol; Haloperidol decanoate; Rivastigmine
• Other Study ID Numbers: ICHYPDEL/002; METC-UMCU 07/236