DeliriumPhase 2LUCIDNCT01956604
The Oslo Study of Clonidine in Elderly Patients With Delirium
A Phase 2 study testing Clonidine in people with Delirium, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Clonidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 10 Apr 2014to 12 Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Delirium
- Being tested
- Clonidine, Placebo
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Clonidine | Experimental | 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. Receives: Drug: Clonidine |
| Placebo (sugar pill) | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDAS (Memorial delirium assessment scale)
Measured: Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks
Secondary outcomes (14)
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
Measured: 2 weeks
Incidence of "full-scale" delirium
- monitored by DSM-5 criteria
Measured: 2 weeks
Severity of delirium
measured by MDAS, OSLA
Measured: 2 weeks
Delirium subtype
Measured by MDAS, OSLA
Measured: 2 weeks
The use of "rescue medication"
Measured: 2 weeks
Length of hospital stay
Measured: Hospital stay
Patient distress
Measured: 2 weeks
Side effects of clonidine
Measured: 4 months
Pharmacokinetic response to clonidine
Measured: 1 week
Pharmacodynamic response to clonidine
Measured: 2 weeks
Biomarkers
Measured: 2 weeks
Institutionalization
Measured: 4 months
Survival
Measured: 4 months
Cognitive function/ independence
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start10 Apr 2014
- Primary completion12 Sep 2017
- Study completion12 Sep 2017
Why it stopped: The inclusion rate was too low, due to the exclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjørn Erik Neerland, MD, Oslo University Hospital
- Investigators
- Torgeir Bruun Wyller, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956604
- Sponsor's protocol ID
- 2013-000815-26
- Other IDs
- 2013-000815-26
- Acronym
- LUCID
- Status last verified
- Oct 2018
- First submitted
- 25 Sep 2013
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 29884231Neerland 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oslo Study of Clonidine in Elderly Patients With Delirium
- ClinicalTrials.gov ID
- NCT01956604
- Acronym / sponsor ID
- LUCID / 2013-000815-26
- Conditions
- Delirium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The inclusion rate was too low, due to the exclusion criteria.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 10 Apr 2014 (actual)
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clonidine | Experimental | Drug: ClonidineClonidine 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 (sugar pill) | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine | Drug | Clonidine |
| Placebo | Drug | Placebo (sugar pill) |
Primary outcome
MDAS (Memorial delirium assessment scale)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks
14 secondary outcomes
Time-to-first delirium
Time frame: 2 weeks
Incidence of "full-scale" delirium
Time frame: 2 weeks
Severity of delirium
Time frame: 2 weeks
Delirium subtype
Time frame: 2 weeks
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
Results and safety
The study was stopped early (reason given: The inclusion rate was too low, due to the exclusion criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Derived from this study: PubMed 29884231Hov 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.
- Derived from this study: PubMed 25887557Neerland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torgeir Bruun Wyller, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clonidine in people with Delirium, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The inclusion rate was too low, due to the exclusion criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDAS (Memorial delirium assessment scale) (time frame: Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01956604, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.