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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tianeptine | Experimental |
| |
| Escitalopram | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tianeptine | Drug | week1 : 25mg/day q.d., week2: 37.5mg/day b.i.d. (12.5mg 1T, 12.5mg 2T |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hamilton Rating Scale for Depression(HAM-D)score from baseline | followed up to 2,4,8,12 weeks from baseline | |
| Changes in Korean version-California Verbal Learnign Test(K-CVLT) total score from baseline | followed up to 4,8,12 weeks from baseline | |
| Changes in Visual Continuous Performance Test(CPT) total score from baseline | followed up to 4,8,12 weeks from baseline | |
| Changes in Raven Progressive Matrices(RPM) total score from baseline | followed up to 4,8,12 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hamilton Rating Scale for Anxiety(HAM-A) score from baseline | followed to 2,4,8,12 weeks from baseline | |
| Changes in Clinical Clinical Global Impression- improvement(CGI-I) | followed to 2,4,8,12 weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
Patients meeting more than one following patient characteristics
Patients with a history or presence of any hypersensitivity to tianeptine, escitalopram or other drugs
Patients who receive formal psychotherapy (e.g. cognitive behavioral therapy, insight-oriented psychoanalysis, interpersonal therapy, etc.) and who have a plan for getting psychotherapy
Patients with any clinically significant abnormality (e.g. hepatic failure, renal failure, cardiovascular disorder, respiratory disorder, gastrointestinal disorder, endocrine disorder, neurological disorder, inflammatory disorder, neoplasm, metabolic disorder, etc.)
Patients who have abnormal ECG and a significant disease according to the investigator's judgment
Patients with any chronic liver or kidney disease
Patients with a family history of long QT syndrome
Patients previously not responders to tianeptine or escitalopram in the treatment of major depressive disorder
Patients who have a suicide risk according to the investigator's judgment
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| Name | Affiliation | Role |
|---|---|---|
| Bum Hee Yu, Ph.D. | Department of Pyschiatry, Sansung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Paik Hospital | Goyang | 411-706 | South Korea | |||
| Inje University Seoul Paik Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26142691 | Derived | Yoo I, Woo JM, Lee SH, Fava M, Mischoulon D, Papakostas GI, Kim EJ, Chung S, Ha JH, Jeon HJ. Influence of anxiety symptoms on improvement of neurocognitive functions in patients with major depressive disorder: A 12-week, multicenter, randomized trial of tianeptine versus escitalopram, the CAMPION study. J Affect Disord. 2015 Oct 1;185:24-30. doi: 10.1016/j.jad.2015.06.038. Epub 2015 Jun 25. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C050504 | tianeptine |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Escitalopram | Drug | week1 : 5mg/day q.d., week2: 10mg/day q.d. |
|
| Change in Response Rate from baseline | followed to 12 weeks from baseline |
| Change in Mini-Mental status examination(MMSE) total score from baseline | followed to 4,8,12 weeks from baseline |
| Change in Sexual Function Scale | followed to 2,4,8,12 weeks from baseline |
| Change in Clinical Global Impression- severity(CGI-S) | followed to 2,4,8,12 weeks from baseline |
| Change in Remission Rate from baseline | followed to 12 weeks from baseline |
| Seoul |
| 100-032 |
| South Korea |
| Asan Medical Center | Seoul | South Korea |
| Eulji Medical College Hospital | Seoul | South Korea |
| Konkuk University Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |