Status Approved
First Submitted Date
2013/01/18
Registered Date
2013/01/22
Last Updated Date
2013/01/18
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0000632 |
|---|---|
| Unique Protocol ID | 3-2008-0122 |
| Public/Brief Title | Study for investigating risk factors, prognostic predictive factors, and neural mechanism of delirium |
| Scientific Title | Functional neuroimaging study for investigating mind-body complex disorders: Functional neuroimaging study for investigating risk factors, prognostic predictive factors, and neural mechanism of delirium |
| Acronym | |
| MFDS Regulated Study | No |
| IND/IDE Protocol | No |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | 3-2008-0122 |
| Approval Date | 2008-11-12 |
| Institutional Review Board Name | Yonsei University, Gangnam Severance Hospital, Institutional Review Board |
| Institutional Review Board Address | |
| Institutional Review Board Telephone | |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Jae-Jin Kim |
| Title | M.D. Ph.D. |
| Telephone | +82-2-2019-3341 |
| Affiliation | Yonsei University Health System, Gangnam Severance Hospital |
| Address | |
| Contact Person for Public Queries | |
| Name | Hyung-Jun Yoon |
| Title | M.D. |
| Telephone | +82-2-2019-3347 |
| Affiliation | Yonsei University Health System, Gangnam Severance Hospital |
| Address | |
| Contact Person for Updating Information | |
| Name | Hyung-Jun Yoon |
| Title | M.D. |
| Telephone | +82-2-2019-3347 |
| Affiliation | Yonsei University Health System, Gangnam Severance Hospital |
| Address | |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Recruiting | |
| Date of First Enrollment | 2008-11-17 Actual | |
| Target Number of Participant | 370 | |
| Primary Completion Date | 2014-11-11 , Anticipated | |
| Study Completion Date | 2015-11-11 , Anticipated | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Yonsei University Health System, Gangnam Severance Hospital | |
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2008-11-17 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Yonsei University |
| Organization Type | University |
| Project ID | 3-2008-0122 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Yonsei University Health System, Gangnam Severance Hospital |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | Delirium induced not only physical and psychological distress of patients, but also was associated with considerable cost of care. Objective of this study was to invetigate risk factors, neural mechanisms, treatment response for typocal or atypical antipsychotics, prognostic facotrs of delirium. An initial functional MRI scan was obtained from patients during an episode of delirium, and a follow-up scan was obtained after resolution ofdelirium. Patients with delirium were assigned to either typical or atypical antipsychotics, and treatment response was evaluated by a standardized rating scale. The disruption of functional neural network will be observed in patients with delirium during an episode of delirium. Treatment response for typical or atypical antipsychotics will be not differ largely in patients with delirium. |
|---|
8. Study Design
| Study Type | Observational Study |
|---|---|
| Observational Study Model | Cohort |
| Time Perspective | Prospective |
| Target Number of Participant | 370 |
| Cohort/Group Number | 1 |
|
Cohort/ Group 1 |
Cohort/Group Label Patient with a diagnosis of delirium |
|
Cohort/Group Description Functional MRI scan was obtained from patients with delirium during an episode of delirium and follow-up scan was obtained after resolution of delirium. Patients with delirium were assigned either typical or atypical antipsychotics |
|
| Biospecimen Collection & Archiving |
Not collect nor Archive |
| Biospecimen Description |
9. Subject Eligibility
| Study Population Description | The subjects enrolled in this study were patients presenting with a mental status change who were referred to a consultation-liaison psychiatric service at a Gangnam Severance Hospital in Korea. To be enrolled in the study, subjects were required to meet the DSM-IV-TR diagnostic criteria for delirium and to be older than 50 years. |
|---|---|
| Sampling Method | Non-Probability sampling |
| Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F05.9)Delirium, unspecified |
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 50Year~100Year |
|
|
Description The subjects enrolled in this study were patients presenting with a mental status change who were referred to a consultation-liaison psychiatric service at a Gangnam Severance Hospital in Korea. To be enrolled in the study, subjects were required to meet the DSM-IV-TR diagnostic criteria for delirium and to be older than 50 years. |
|
| Exclusion Criteria |
1. a diagnosis of dementia or comorbid psychiatric disorder 2. suffering of a terminal illness 3. a history of prolonged QTc interval 4. a presence of hearing loss 5. a history of neuroleptic malignant syndrome 6. use fo antipsychotic medication before referral 7. excluding patients who refused to provide informed consent |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | he Korean version of the Delirium Rating Scale-Revised-98 |
|
| Timepoint | All the subjects were evaluated at baseline and on the second, the fourth, and sixth days at the same time of day |
|
| Secondary Outcome(s) 1 | ||
| Outcome | the Korean version of the Mini Mental Status Examination |
|
| Timepoint | All the subjects were evaluated at baseline and on the second, the fourth, and sixth days at the same time of day |
|
11. Study Results and Publication
| Result Registered |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | Not provided at time of Registration |
|---|
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