The Oslo Study of Clonidine in Elderly Patients With Delirium (LUCID)
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|ClinicalTrials.gov Identifier: NCT01956604|
Recruitment Status : Terminated (The inclusion rate was too low, due to the exclusion criteria.)
First Posted : October 8, 2013
Last Update Posted : October 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Delirium||Drug: Clonidine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Oslo Study of Clonidine in Elderly Patients With Delirium|
|Actual Study Start Date :||April 10, 2014|
|Actual Primary Completion Date :||September 12, 2017|
|Actual Study Completion Date :||September 12, 2017|
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.
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.
- MDAS (Memorial delirium assessment scale) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks ]
- Time-to-first delirium [ Time Frame: 2 weeks ]
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
- Incidence of "full-scale" delirium [ Time Frame: 2 weeks ]• monitored by DSM-5 criteria
- Severity of delirium [ Time Frame: 2 weeks ]measured by MDAS, OSLA
- Delirium subtype [ Time Frame: 2 weeks ]Measured by MDAS, OSLA
- The use of "rescue medication" [ Time Frame: 2 weeks ]
- Length of hospital stay [ Time Frame: Hospital stay ]
- Patient distress [ Time Frame: 2 weeks ]
- Side effects of clonidine [ Time Frame: 4 months ]
- Pharmacokinetic response to clonidine [ Time Frame: 1 week ]
- Pharmacodynamic response to clonidine [ Time Frame: 2 weeks ]
- Biomarkers [ Time Frame: 2 weeks ]
- Institutionalization [ Time Frame: 4 months ]
- Survival [ Time Frame: 4 months ]
- Cognitive function/ independence [ Time Frame: 4 months ]
- Exposure-response analyses [ Time Frame: 4 months ]We will also do per protocol analyses and exposure-response analyses based on measurements of the plasma concentration of clonidine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956604
|Oslo University Hospital|
|Oslo, Norway, N-0424|
|Principal Investigator:||Torgeir Bruun Wyller, MD PhD||Oslo University Hospital|