Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder

NCT01309776 | Completed Phase 4

• 1 other identifier: 2010-11-029
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 6

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• 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

Study Arms (2)

Tianeptine

EXPERIMENTAL

Drug: Tianeptine

Escitalopram

ACTIVE COMPARATOR

Drug: Escitalopram

Interventions

Tianeptine DRUG

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

Also known as: Stablon

Tianeptine

Escitalopram DRUG

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

Escitalopram

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients fulfilling DSM-IV-TR(American Psychiatric Association, 4thedition, 2000) criteria for Major Depressive Disorder diagnosis
• The male or female patients aged more than 40 years
• Patients able to hand in written informed consent before his/her participation in this clinical study
• 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. ))
• Patients who have subjective cognitive impairment, or who have objective cognitive impairment (MMSE ≤26) without subjective cognitive impairment
• HAM-D(17-items) total score ≥ 16

You may not qualify if:

• Patients meeting more than one following patient characteristics
• 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)
• Patients with any substance-related disorder (excluding nicotine) within the past 12 months, as defined in DSM-IV-TR
• Patients with a history or presence of any neurological disorders (e.g. multiple sclerosis, seizure, etc.)
• Patients with any axis II disorder that prone to interfere with the evaluation of the study
• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (6)

Inje University Paik Hospital

Goyang, 411-706, South Korea

Location

Inje University Seoul Paik Hospital

Seoul, 100-032, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Eulji Medical College Hospital

Seoul, South Korea

Location

Konkuk University Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26142691 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

tianeptine; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bum Hee Yu, Ph.D.

  Department of Pyschiatry, Sansung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 7, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

KR (6)