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Dose Milnacipran Prevent Depressive Symptoms in Patients With Acute Stroke?

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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
Sponsor:
Information provided by:
Chang Gung Memorial Hospital

Study Description
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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 rate.We are going to conduct a trial of prevention of psot stroke depression by prescribing milnacipran in advance.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Depression Drug: milnacipran Drug: placebo Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : September 2007
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Depression rating scale [ Time Frame: 0,1,3,6,9,12th ]

Secondary Outcome Measures :
  1. Taiwanese depression questionnaire, quality of life, london handicap scale [ Time Frame: 0,1,3,6,9,12th month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

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


Contacts
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Contact: Jian-An Su, MD 886-5-3621000 ext 2313 jian.7715@gmail.com

Locations
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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         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Hin-Yeung Tsang, MD,PHD Chang Gung Memorial Hospital
More Information
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Responsible Party: Centapharm Inc Flory Co Ltd
ClinicalTrials.gov Identifier: NCT00606203    
Other Study ID Numbers: 96-0083
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Milnacipran
Levomilnacipran
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs