Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-25 @ 7:21 AM
Study NCT ID:
NCT01956604
Status:
TERMINATED
Last Update Posted:
2018-10-31
First Post:
2013-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Oslo Study of Clonidine in Elderly Patients With Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'The inclusion rate was too low, due to the exclusion criteria.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-29', 'studyFirstSubmitDate': '2013-09-25', 'studyFirstSubmitQcDate': '2013-10-07', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exposure-response analyses', 'timeFrame': '4 months', 'description': 'We will also do per protocol analyses and exposure-response analyses based on measurements of the plasma concentration of clonidine'}], 'primaryOutcomes': [{'measure': 'MDAS (Memorial delirium assessment scale)', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Time-to-first delirium', 'timeFrame': '2 weeks', 'description': '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:\n\n• time to first resolution, monitored by DSM-5 criteria'}, {'measure': 'Incidence of "full-scale" delirium', 'timeFrame': '2 weeks', 'description': '• monitored by DSM-5 criteria'}, {'measure': 'Severity of delirium', 'timeFrame': '2 weeks', 'description': 'measured by MDAS, OSLA'}, {'measure': 'Delirium subtype', 'timeFrame': '2 weeks', 'description': 'Measured by MDAS, OSLA'}, {'measure': 'The use of "rescue medication"', 'timeFrame': '2 weeks'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Hospital stay'}, {'measure': 'Patient distress', 'timeFrame': '2 weeks'}, {'measure': 'Side effects of clonidine', 'timeFrame': '4 months'}, {'measure': 'Pharmacokinetic response to clonidine', 'timeFrame': '1 week'}, {'measure': 'Pharmacodynamic response to clonidine', 'timeFrame': '2 weeks'}, {'measure': 'Biomarkers', 'timeFrame': '2 weeks'}, {'measure': 'Institutionalization', 'timeFrame': '4 months'}, {'measure': 'Survival', 'timeFrame': '4 months'}, {'measure': 'Cognitive function/ independence', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Delirium']}, 'referencesModule': {'references': [{'pmid': '29884231', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '25887557', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Delirium ("acute confusional state")is characterized by an acute decline in attention and cognition, and is a common clinical syndrome in elderly patients.\n\nThe 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient \\> 65 years old admitted to the Medical department\n* Delirium or subsyndromal delirium diagnosed within the last 48 hours\n* Signed informed consent from patient or relatives\n* Expected cooperation of the patients for the treatment and follow up\n\nExclusion Criteria:\n\n* 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\n* Symptomatic hypotension or orthostatic hypotension, or a systolic BP \\<120 at the time of inclusion\n* Ischemic stroke within the last 3 months or critical peripheral ischemia\n* 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).\n* A diagnosis of polyneuropathy or pheochromocytoma\n* Renal insufficiency (estimated GFR\\<30 ml/min according to the MDRD formula).\n* Body weight \\< 45 kg.\n* Considered as moribund on admission.\n* Not able to take oral medications\n* Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin\n* Previously included in this study\n* Adverse reactions to clonidine or excipients (lactose, saccharose)\n* Not speaking or reading Norwegian\n* Any other condition as evaluated by the treating physician\n* Admitted to the ICU'}, 'identificationModule': {'nctId': 'NCT01956604', 'acronym': 'LUCID', 'briefTitle': 'The Oslo Study of Clonidine in Elderly Patients With Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'The Oslo Study of Clonidine in Elderly Patients With Delirium', 'orgStudyIdInfo': {'id': '2013-000815-26'}, 'secondaryIdInfos': [{'id': '2013-000815-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clonidine', 'description': 'Clonidine administered orally:\n\nDay 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.', 'interventionNames': ['Drug: Clonidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (sugar pill)', 'description': 'Placebo administered orally (identical capsula as for expirimental drug):\n\nDay 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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Clonidine', 'type': 'DRUG', 'armGroupLabels': ['Clonidine']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo (sugar pill)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Torgeir Bruun Wyller, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor, PhD student', 'investigatorFullName': 'Bjørn Erik Neerland, MD', 'investigatorAffiliation': 'Oslo University Hospital'}}}}