Clinical trial NCT01309776: Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder
Official title: Comparison of Tianeptine Versus Escitalopram for the Treatment of Depression and Cognitive Impairment in Patients With Major Depressive Disorder: A Randomized, Multicenter, Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-03-07
Enrollment: 164
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Hamilton Rating Scale for Depression(HAM-D)score from baseline
timeFrame: followed up to 2,4,8,12 weeks from baseline
measure: Changes in Korean version-California Verbal Learnign Test(K-CVLT) total score from baseline
timeFrame: followed up to 4,8,12 weeks from baseline
measure: Changes in Visual Continuous Performance Test(CPT) total score from baseline
timeFrame: followed up to 4,8,12 weeks from baseline
measure: Changes in Raven Progressive Matrices(RPM) total score from baseline
timeFrame: followed up to 4,8,12 weeks from baseline
Secondary outcomes:
measure: Changes in Hamilton Rating Scale for Anxiety(HAM-A) score from baseline
timeFrame: followed to 2,4,8,12 weeks from baseline
measure: Changes in Clinical Clinical Global Impression- improvement(CGI-I)
timeFrame: followed to 2,4,8,12 weeks from baseline
measure: Change in Response Rate from baseline
timeFrame: followed to 12 weeks from baseline
measure: Change in Mini-Mental status examination(MMSE) total score from baseline
timeFrame: followed to 4,8,12 weeks from baseline
measure: Change in Sexual Function Scale
timeFrame: followed to 2,4,8,12 weeks from baseline
measure: Change in Clinical Global Impression- severity(CGI-S)
timeFrame: followed to 2,4,8,12 weeks from baseline
measure: Change in Remission Rate from baseline
timeFrame: followed to 12 weeks from baseline
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Inje University Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji Medical College Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of Pyschiatry, Sansung Medical Center
name: Bum Hee Yu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.