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The Oslo Study of Clonidine in Elderly Patients With Delirium

Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Delirium

Intervention: Clonidine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Oslo University Hospital

Official(s) and/or principal investigator(s):
Torgeir Bruun Wyller, MD PhD, Principal Investigator, Affiliation: Oslo University Hospital

Overall contact:
Torgeir Bruun Wyller, MD PhD, Phone: +47 91166682, Email: t.b.wyller@medisin.uio.no


Delirium ("acute confusional state")is characterized by an acute decline in attention and cognition, and is a common clinical syndrome in elderly patients. The purpose of this randomised, controlled, parallel group pilot trial is to explore superiority of clonidine vs placebo in decreasing delirium in patients diagnosed delirium at the acute geriatric ward. We will also study the feasibility of oral clonidine in a geriatric ward and effects of clonidine upon a variety of outcomes as a means to design a more definite study later.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: MDAS (Memorial delirium assessment scale)

Secondary outcome:

Time-to-first delirium

Incidence of "full-scale" delirium

Severity of delirium

Delirium subtype

The use of "rescue medication"

Length of hospital stay

Patient distress

Side effects of clonidine

Pharmacokinetic response to clonidine

Pharmacodynamic response to clonidine




Cognitive function/ independence


Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patient > 65 years old admitted to the Medical department

- Delirium or subsyndromal delirium diagnosed within the last 48 hours

- Signed informed consent from patient or relatives

- Expected cooperation of the patients for the treatment and follow up

Exclusion Criteria:

- Symptomatic bradycardia, bradycardia due to sick-sinus-syndrome, second- or third-

degree AV-block (not treated With pacemaker) or any other reason causing HR <50 bpm at time of inclusion

- Symptomatic hypotension or orthostatic hypotension, or a systolic BP <120 at the time

of inclusion

- Ischemic stroke within the last 3 months or critical peripheral ischemia

- Acute coronary syndrome, unstable or severe coronary heart disease (symptoms at

minimal physical activity; NYHA 3 and 4) and moderate to severe heart failure (NYHA 3 and 4).

- A diagnosis of polyneuropathy or pheochromocytoma

- Renal insufficiency (estimated GFR<30 ml/min according to the MDRD formula).

- Body weight < 45 kg.

- Considered as moribund on admission.

- Not able to take oral medications

- Current use of tricyclic antidepressants, monoamine reuptake inhibitors or


- Previously included in this study

- Adverse reactions to clonidine or excipients (lactose, saccharose)

- Not speaking or reading Norwegian

- Any other condition as evaluated by the treating physician

- Admitted to the ICU

Locations and Contacts

Torgeir Bruun Wyller, MD PhD, Phone: +47 91166682, Email: t.b.wyller@medisin.uio.no

Oslo University Hospital, Oslo N-0424, Norway; Recruiting
Bruun Wyller, Email: t.b.wyller@medisin.uio.no
Bjørn Erik Neerland, MD, Sub-Investigator
Karen Roksund Hov, MD, Sub-Investigator
Additional Information

Starting date: April 2014
Last updated: January 12, 2015

Page last updated: August 20, 2015

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