Ignite Creation Date:
2024-05-05 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 9:43 AM
Study NCT ID:
NCT00606203
Status:
UNKNOWN
Last Update Posted:
2008-10-17
First Post:
2008-01-21
Brief Title:
Dose Milnacipran Prevent Depressive Symptoms in Patients With Acute Stroke
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Depression is one of the important psychiatric sequelae after stroke The prevalence of post stroke depression PSD is approximately 20-40 Depression comorbid with stroke has been found to be associated with increased disability cognitive function decline poorer rehabilitation outcome and higher mortality rateWe are going to conduct a trial of prevention of psot stroke depression by prescribing milnacipran in advance
Detailed Description:
First visit visit 0 will be performed in the first three days after patient is admitted to the neurological ward due to ischemic stroke The purposes of the initial assessment include demographic data collection age gender stroke location initial interview to exclude past history of depression substance abuse or psychosis In addition Ham-D CGI NIHSS Barthel index MMSE please refer to the instruments listed below are performed in the first visit Patients whose MMSE15 or Ham-D10 will be excluded
After being enrolled patients stratified with stroke locations are randomized assigned to two groups group A treatment group with active antidepressant or group B placebo group Variables such as age gender severity of the NIHSS MMSE and Ham-D will be controlled during assignment and the cytokine level will be checked also as baseline The cytokine that will be checked includes IL-1 IL-6 TNF-αIFN-γ that were considered pro-inflammatory cytokine The anti-inflammatory cytokine of IL-4 IL-10 and TGF-β will be checked also Patients in group A will take Milnacipran 50mg 1 QD from the first day of being enrolled into the study and will titrate to 1 BID one week later Patients in both groups will be followed at 1st 3rd 6th 9th and 12th month after stroke The Ham-D TDQ NIHSS Barthel index CGI MMSE and cytokines will be assessed in each of the check point Patients in either group A or group B will be withdrawn from the study and referred to psychiatric clinics for further alternative management if they developed depression Ham-D17 Cytokine levels in depressed patients will be compared with the randomly selected controlled group All the interviewers are blinded to the patients medication If patients drop out the reason will be clarified and recorded Patients who suffered from recurrent stroke during study period still keep the same protocol that are followed continuously for one year unless patients request for withdrawal
After being enrolled patients stratified with stroke locations are randomized assigned to two groups group A treatment group with active antidepressant or group B placebo group Variables such as age gender severity of the NIHSS MMSE and Ham-D will be controlled during assignment and the cytokine level will be checked also as baseline The cytokine that will be checked includes IL-1 IL-6 TNF-αIFN-γ that were considered pro-inflammatory cytokine The anti-inflammatory cytokine of IL-4 IL-10 and TGF-β will be checked also Patients in group A will take Milnacipran 50mg 1 QD from the first day of being enrolled into the study and will titrate to 1 BID one week later Patients in both groups will be followed at 1st 3rd 6th 9th and 12th month after stroke The Ham-D TDQ NIHSS Barthel index CGI MMSE and cytokines will be assessed in each of the check point Patients in either group A or group B will be withdrawn from the study and referred to psychiatric clinics for further alternative management if they developed depression Ham-D17 Cytokine levels in depressed patients will be compared with the randomly selected controlled group All the interviewers are blinded to the patients medication If patients drop out the reason will be clarified and recorded Patients who suffered from recurrent stroke during study period still keep the same protocol that are followed continuously for one year unless patients request for withdrawal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None