Dose Milnacipran Prevent Depressive Symptoms in Patients With Acute Stroke?
Recruitment status was Recruiting
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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: | 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 ]
| 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 |
|---|---|
|
Experimental: A
The aims of this study are to investigate the prophylactic effect of milnacipran in post stroke depression.
|
Drug: milnacipran
taking milnacipran(50) 1#bid after stoke to prevent the occurence of depression
|
|
Placebo Comparator: B
Placebo
|
Drug: placebo
placebo
|
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 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:
- Consecutive admission due to first or recurrent ischemic stroke (image proved) and stroke occurred in preceding 4 weeks before admission. The onset of stroke was defined as the occurrence of abnormal neurological symptoms according to the patients' statement. The following period is 12 months after being included (for the first and third study aims), and follow for another 24 months to study the immunological aspect of PSD (for the second study aim).
Exclusion Criteria:
- TIA (transit ischemic attack)
- Impairment of communication or cognitive function (MMSE<15)
- Past history of depression, psychosis, severe substance abuse
- Taking antidepressants at least 2 weeks prior to stroke
- Concurrent possible depression (Ham-D>10)
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
No publications provided
| Responsible Party: | Centapharm Inc Flory Co Ltd |
| ClinicalTrials.gov Identifier: | NCT00606203 History of Changes |
| Other Study ID Numbers: | 96-0083 |
| Study First Received: | January 21, 2008 |
| Last Updated: | October 15, 2008 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Stroke Cerebral Infarction Behavioral Symptoms Mood Disorders Mental Disorders Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
Milnacipran Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents |
ClinicalTrials.gov processed this record on May 22, 2013