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TerminatedNCT01956604LUCIDUpdated Oct 31, 2018

The Oslo Study of Clonidine in Elderly Patients With Delirium

A Phase 2 interventional study of Clonidine and Placebo in Delirium, sponsored by Oslo University Hospital. Terminated at 1 site in Norway. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-10-31.

Sponsored by Oslo University Hospital · Phase 2, Interventional, and Treatment

Why this study was terminated
The inclusion rate was too low, due to the exclusion criteria.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Delirium

Browse trials for

03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 20 is below the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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 ciclosporin
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Clonidine

    Clonidine administered orally: Day 1/loading doses: 75µg every 3rd hour until maximum 4 doses. Day 2-7/maintenance doses: 75µg BID. Duration of treatment is maximum 7 days.

    Drug: Clonidine

  • Placebo comparator
    Placebo (sugar pill)

    Placebo administered orally (identical capsula as for expirimental drug): Day 1/loading doases: 75µg every 3rd hour until maximum 4 doses. Day 2-7/maintenance doses: 75µg BID. Duration of treatment is maximum 7 days.

    Drug: Placebo

Interventions

  • DrugClonidine
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. MDAS (Memorial delirium assessment scale)

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks

Secondary outcomes

  1. Time-to-first delirium

    We will compare the actively treated group with the placebo group (also with subanalyses for subsyndromal delirium and hypoactive/ hyperactive/ mixed delirium) with respect to: • time to first resolution, monitored by DSM-5 criteria

    Time frame: 2 weeks

  2. Incidence of "full-scale" delirium

    • monitored by DSM-5 criteria

    Time frame: 2 weeks

  3. Severity of delirium

    measured by MDAS, OSLA

    Time frame: 2 weeks

  4. Delirium subtype

    Measured by MDAS, OSLA

    Time frame: 2 weeks

  5. The use of "rescue medication"

    Time frame: 2 weeks

  6. Length of hospital stay

    Time frame: Hospital stay

  7. Patient distress

    Time frame: 2 weeks

  8. Side effects of clonidine

    Time frame: 4 months

  9. Pharmacokinetic response to clonidine

    Time frame: 1 week

  10. Pharmacodynamic response to clonidine

    Time frame: 2 weeks

  11. Biomarkers

    Time frame: 2 weeks

  12. Institutionalization

    Time frame: 4 months

  13. Survival

    Time frame: 4 months

  14. Cognitive function/ independence

    Time frame: 4 months

Other outcomes

  1. Exposure-response analyses

    We will also do per protocol analyses and exposure-response analyses based on measurements of the plasma concentration of clonidine

    Time frame: 4 months

07

Study locations

1 site
  • Oslo University Hospital
    Oslo, N-0424, Norway
08

References and documents

Publications

  • Hov KR, Neerland BE, Andersen AM, Undseth O, Wyller VB, MacLullich AMJ, Skovlund E, Qvigstad E, Wyller TB. The use of clonidine in elderly patients with delirium; pharmacokinetics and hemodynamic responses. BMC Pharmacol Toxicol. 2018 Jun 8;19(1):29. doi: 10.1186/s40360-018-0218-1. PubMed 29884231 ↗
  • Neerland BE, Hov KR, Bruun Wyller V, Qvigstad E, Skovlund E, MacLullich AM, Bruun Wyller T. The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial. BMC Geriatr. 2015 Feb 10;15:7. doi: 10.1186/s12877-015-0006-3. PubMed 25887557 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01956604
Lead sponsor
Oslo University Hospital
Responsible party
Bjørn Erik Neerland, MD (Medical doctor, PhD student, Oslo University Hospital) — Principal investigator
First posted
Oct 8, 2013
Start date
Apr 10, 2014
Primary completion
Sep 12, 2017
Completion
Sep 12, 2017
Last update
Oct 31, 2018

Study contacts

Torgeir Bruun Wyller, MD PhD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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