The primary object of this study is to confirm the superiority of tianeptine compared to escitalopram on effects that improves subjective and objective cognitive impairments in patients suffering from major depressive disorder.
Along with depressive symptoms, subjective and objective cognitive impairments are frequently complained by the patients with major depressive disorder. Tianeptine acts on glutamate system and is known as a promising drug for improving cognitive impairment. The present study aims to confirm the superiority of tianeptine compared to escitalopram on effects that improves subjective and objective cognitive impairments after a 12-week treatment in patients suffering from major depressive disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
week1 : 25mg/day q.d., week2: 37.5mg/day b.i.d. (12.5mg 1T, 12.5mg 2T
week1 : 5mg/day q.d., week2: 10mg/day q.d.
Inje University Paik Hospital
Goyang, South Korea
Inje University Seoul Paik Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Eulji Medical College Hospital
Seoul, South Korea
Changes in Hamilton Rating Scale for Depression(HAM-D)score from baseline
Time frame: followed up to 2,4,8,12 weeks from baseline
Changes in Korean version-California Verbal Learnign Test(K-CVLT) total score from baseline
Time frame: followed up to 4,8,12 weeks from baseline
Changes in Visual Continuous Performance Test(CPT) total score from baseline
Time frame: followed up to 4,8,12 weeks from baseline
Changes in Raven Progressive Matrices(RPM) total score from baseline
Time frame: followed up to 4,8,12 weeks from baseline
Changes in Hamilton Rating Scale for Anxiety(HAM-A) score from baseline
Time frame: followed to 2,4,8,12 weeks from baseline
Changes in Clinical Clinical Global Impression- improvement(CGI-I)
Time frame: followed to 2,4,8,12 weeks from baseline
Change in Response Rate from baseline
Time frame: followed to 12 weeks from baseline
Change in Mini-Mental status examination(MMSE) total score from baseline
Time frame: followed to 4,8,12 weeks from baseline
Change in Sexual Function Scale
Time frame: followed to 2,4,8,12 weeks from baseline
Change in Clinical Global Impression- severity(CGI-S)
Time frame: followed to 2,4,8,12 weeks from baseline
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Konkuk University Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Change in Remission Rate from baseline
Time frame: followed to 12 weeks from baseline