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Dose Milnacipran Prevent Depressive Symptoms in Patients With Acute Stroke?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00606203
First received: January 21, 2008
Last updated: October 15, 2008
Last verified: October 2008
  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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Hamilton Depression rating scale [ Time Frame: 0,1,3,6,9,12th ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606203

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

Locations
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
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
Stroke
Behavioral Symptoms
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Milnacipran
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014