Dose Milnacipran Prevent Depressive Symptoms in Patients With Acute Stroke?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00606203|
Recruitment Status : Unknown
Verified October 2008 by Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : February 1, 2008
Last Update Posted : October 17, 2008
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Depression||Drug: milnacipran Drug: placebo||Not Applicable|
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 Patients in either group A or group B will be withdrawn from the study and referred to psychiatric clinics for further alternative management if they developed depression (Ham-D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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||September 2011|
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
- Hamilton Depression rating scale [ Time Frame: 0,1,3,6,9,12th ]
- Taiwanese depression questionnaire, quality of life, london handicap scale [ Time Frame: 0,1,3,6,9,12th month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606203
|Contact: Jian-An Su, MD||886-5-3621000 ext email@example.com|
|Chang Gung Memorial Hospital||Recruiting|
|Chiayi, Taiwan, 613|
|Contact: Jian-An Su, MD +886-5-3621000 ext 2313 firstname.lastname@example.org|
|Principal Investigator: Shih-Young Chou, MD|
|Principal Investigator: Ching-Shu Tsai, MD|
|Principal Investigator:||Hin-Yeung Tsang, MD,PHD||Chang Gung Memorial Hospital|