Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Tianeptine; Drug: Escitalopram

• Registration Number: NCT01309776
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-07
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

1. Patients fulfilling DSM-IV-TR(American Psychiatric Association, 4thedition, 2000) criteria for Major Depressive Disorder diagnosis
2. The male or female patients aged more than 40 years
3. Patients able to hand in written informed consent before his/her participation in this clinical study
4. Women of childbearing potential with negative pregnancy test during screening phase and entire study period (during entire study period, able to clearly agree with effective contraception such as contraceptive pill, progesterone injection, levonorgestrel implant, estrogen ring, transdermal contraceptive agent, intra-uterine contraceptive device, sterilization operation of husband, and double contraceptive method (e.g. combination of condom, pessary, spermicide, etc. ))
5. Patients who have subjective cognitive impairment, or who have objective cognitive impairment (MMSE ≤26) without subjective cognitive impairment
6. HAM-D(17-items) total score ≥ 16

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Exclusion Criteria

1. Patients meeting more than one following patient characteristics

   1. Patients fulfilling DSM-IV-TR current or past diagnosis of any psychiatric disorders other than major depressive disorder (i.e. manic or hypomanic episode, schizophrenia, delirium, dementia, eating disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, major depressive disorder with psychotic features, mental retardation, organic brain disorder, or psychiatric disorders due to general medical condition, according to DSM-IV-TR)
   2. Patients with any substance-related disorder (excluding nicotine) within the past 12 months, as defined in DSM-IV-TR
   3. Patients with a history or presence of any neurological disorders (e.g. multiple sclerosis, seizure, etc.)
   4. Patients with any axis II disorder that prone to interfere with the evaluation of the study

2. Patients with a history or presence of any hypersensitivity to tianeptine, escitalopram or other drugs

3. Patients who receive formal psychotherapy (e.g. cognitive behavioral therapy, insight-oriented psychoanalysis, interpersonal therapy, etc.) and who have a plan for getting psychotherapy

4. 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.)

5. Patients who have abnormal ECG and a significant disease according to the investigator's judgment

6. Patients with any chronic liver or kidney disease

7. Patients with a family history of long QT syndrome

8. Patients previously not responders to tianeptine or escitalopram in the treatment of major depressive disorder

9. Patients who have a suicide risk according to the investigator's judgment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tianeptine	Tianeptine	-
Escitalopram	Escitalopram	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (6)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Inje University Paik Hospital; 🇰🇷 Goyang, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Inje University Seoul Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Eulji Medical College Hospital; 🇰🇷 Seoul, Korea, Republic of