Dose Milnacipran Prevent Depressive Symptoms in Patients With Acute Stroke?

NCT00606203 | Unknown

• 1 other identifier: 96-0083
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression rating scale

  0,1,3,6,9,12th

Secondary Outcomes (1)

• Taiwanese depression questionnaire, quality of life, london handicap scale

  0,1,3,6,9,12th month

Study Arms (2)

A

EXPERIMENTAL

The aims of this study are to investigate the prophylactic effect of milnacipran in post stroke depression.

Drug: milnacipran

B

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

milnacipran DRUG

taking milnacipran(50) 1#bid after stoke to prevent the occurence of depression

A

placebo DRUG

placebo

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Chiayi City, 613, Taiwan

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Depression

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hin-Yeung Tsang, MD,PHD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-An Su, MD

CONTACT

886-5-3621000; jian.7715@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: February 1, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2011
• Last Updated: October 17, 2008

Record last verified: 2008-10

Locations

TW (1)