Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder

NCT ID: NCT01309776

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-09-30

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tianeptine

Group Type: EXPERIMENTAL

Tianeptine

Intervention Type: DRUG

week1 : 25mg/day q.d., week2: 37.5mg/day b.i.d. (12.5mg 1T, 12.5mg 2T

Escitalopram

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

week1 : 5mg/day q.d., week2: 10mg/day q.d.

Interventions

Tianeptine

week1 : 25mg/day q.d., week2: 37.5mg/day b.i.d. (12.5mg 1T, 12.5mg 2T

Intervention Type: DRUG

Escitalopram

week1 : 5mg/day q.d., week2: 10mg/day q.d.

Intervention Type: DRUG

Other Intervention Names

Stablon

Eligibility Criteria

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

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bum-Hee Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bum Hee Yu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Pyschiatry, Sansung Medical Center

Locations

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

Konkuk University Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 26142691 (View on PubMed)

Other Identifiers

2010-11-029

Identifier Type: -

Identifier Source: org_study_id