Dose Milnacipran Prevent Depressive Symptoms in Patients With Acute Stroke?
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
- Hamilton Depression rating scale [ Time Frame: 0,1,3,6,9,12th ] [ Designated as safety issue: No ]
- Taiwanese depression questionnaire, quality of life, london handicap scale [ Time Frame: 0,1,3,6,9,12th month ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
The aims of this study are to investigate the prophylactic effect of milnacipran in post stroke depression.
taking milnacipran(50) 1#bid after stoke to prevent the occurence of depression
Placebo Comparator: B
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 MMSE<15 or Ham-D>10 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-α,IFN-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 Patients in either group A or group B will be withdrawn from the study and referred to psychiatric clinics for further alternative management if they developed depression (Ham-D>17). Cytokine levels in depressed patients will be compared with the randomly selected controlled group. All the interviewers are blinded to the patient's 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606203
|Chang Gung Memorial Hospital|
|Chiayi, Taiwan, 613|
|Principal Investigator:||Hin-Yeung Tsang, MD,PHD||Chang Gung Memorial Hospital|