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| Sponsored by: |
Chang Gung Memorial Hospital |
|---|---|
| Information provided by: | Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00606203 |
Purpose
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 rate.We are going to conduct a trial of prevention of psot stroke depression by prescribing milnacipran in advance.
| Condition | Intervention |
|---|---|
|
Ischemic Stroke Depression |
Drug: milnacipran Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Estimated Enrollment: | 120 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
The aims of this study are to investigate the prophylactic effect of milnacipran in post stroke depression.
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Drug: milnacipran
taking milnacipran(50) 1#bid after stoke to prevent the occurence of depression
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B: Placebo Comparator
Placebo
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Drug: placebo
placebo
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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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jian-An Su, MD | 886-5-3621000 ext 2313 | jian.7715@gmail.com |
| Taiwan | |
| Chang Gung Memorial Hospital | Recruiting |
| Chiayi, Taiwan, 613 | |
| Contact: Jian-An Su, MD +886-5-3621000 ext 2313 jian.7715@gmail.com | |
| Principal Investigator: Shih-Young Chou, MD | |
| Principal Investigator: Ching-Shu Tsai, MD | |
| Principal Investigator: | Hin-Yeung Tsang, MD,PHD | Chang Gung Memorial Hospital |
More Information
| Responsible Party: | Centapharm Inc Flory Co Ltd ( Centapharm Inc Flory Co Ltd ) |
| Study ID Numbers: | 96-0083 |
| Study First Received: | January 21, 2008 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00606203 History of Changes |
| Health Authority: | Taiwan: Department of Health |
|
Neurotransmitter Agents Depression Adrenergic Agents Cerebral Infarction Stroke Psychotropic Drugs Vascular Diseases Central Nervous System Diseases Ischemia |
Depressive Disorder Brain Diseases Cerebrovascular Disorders Serotonin Uptake Inhibitors Serotonin Behavioral Symptoms Milnacipran Antidepressive Agents |
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Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Stroke Nervous System Diseases Psychotropic Drugs Vascular Diseases Central Nervous System Diseases |
Brain Diseases Cerebrovascular Disorders Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Milnacipran Serotonin Agents Therapeutic Uses Cardiovascular Diseases Central Nervous System Agents Antidepressive Agents |
