Dose Milnacipran Prevent Depressive Symptoms in Patients With Acute Stroke?

Last updated: October 15, 2008
Sponsor: Chang Gung Memorial Hospital
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Depression

Thrombosis

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT00606203
96-0083
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consecutive admission due to first or recurrent ischemic stroke (image proved) andstroke occurred in preceding 4 weeks before admission. The onset of stroke was definedas the occurrence of abnormal neurological symptoms according to the patients'statement. The following period is 12 months after being included (for the first andthird study aims), and follow for another 24 months to study the immunological aspectof PSD (for the second study aim).

Exclusion

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)

Study Design

Total Participants: 120
Study Start date:
September 01, 2007
Estimated Completion Date:
September 30, 2011

Study 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

Connect with a study center

  • Chang Gung Memorial Hospital

    Chiayi, 613
    Taiwan

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.