Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder

Last updated: January 24, 2013
Sponsor: Samsung Medical Center
Overall Status: Completed

Phase

4

Condition

Depression

Affective Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT01309776
2010-11-029
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thisclinical study

  4. Women of childbearing potential with negative pregnancy test during screening phaseand entire study period (during entire study period, able to clearly agree witheffective contraception such as contraceptive pill, progesterone injection,levonorgestrel implant, estrogen ring, transdermal contraceptive agent, intra-uterinecontraceptive device, sterilization operation of husband, and double contraceptivemethod (e.g. combination of condom, pessary, spermicide, etc. ))

  5. Patients who have subjective cognitive impairment, or who have objective cognitiveimpairment (MMSE ≤26) without subjective cognitive impairment

  6. HAM-D(17-items) total score ≥ 16

Exclusion

Exclusion Criteria:

  1. Patients meeting more than one following patient characteristics

  2. Patients fulfilling DSM-IV-TR current or past diagnosis of any psychiatricdisorders other than major depressive disorder (i.e. manic or hypomanic episode,schizophrenia, delirium, dementia, eating disorder, obsessive-compulsivedisorder, panic disorder, post-traumatic stress disorder, major depressivedisorder with psychotic features, mental retardation, organic brain disorder, orpsychiatric disorders due to general medical condition, according to DSM-IV-TR)

  3. Patients with any substance-related disorder (excluding nicotine) within the past 12 months, as defined in DSM-IV-TR

  4. Patients with a history or presence of any neurological disorders (e.g. multiplesclerosis, seizure, etc.)

  5. Patients with any axis II disorder that prone to interfere with the evaluation ofthe study

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

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

  8. Patients with any clinically significant abnormality (e.g. hepatic failure, renalfailure, cardiovascular disorder, respiratory disorder, gastrointestinal disorder,endocrine disorder, neurological disorder, inflammatory disorder, neoplasm, metabolicdisorder, etc.)

  9. Patients who have abnormal ECG and a significant disease according to theinvestigator's judgment

  10. Patients with any chronic liver or kidney disease

  11. Patients with a family history of long QT syndrome

  12. Patients previously not responders to tianeptine or escitalopram in the treatment ofmajor depressive disorder

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

Study Design

Total Participants: 164
Study Start date:
March 01, 2011
Estimated Completion Date:
September 30, 2012

Study 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.

Connect with a study center

  • Inje University Paik Hospital

    Goyang, 411-706
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Eulji Medical College Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Inje University Seoul Paik Hospital

    Seoul, 100-032
    Korea, Republic of

    Site Not Available

  • Konkuk University Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

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