Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder (CAMPION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bum-Hee Yu, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01309776
First received: March 2, 2011
Last updated: January 24, 2013
Last verified: January 2013

March 2, 2011
January 24, 2013
March 2011
September 2012   (final data collection date for primary outcome measure)
  • Changes in Hamilton Rating Scale for Depression(HAM-D)score from baseline [ Time Frame: followed up to 2,4,8,12 weeks from baseline ] [ Designated as safety issue: No ]
  • Changes in Korean version-California Verbal Learnign Test(K-CVLT) total score from baseline [ Time Frame: followed up to 4,8,12 weeks from baseline ] [ Designated as safety issue: No ]
  • Changes in Visual Continuous Performance Test(CPT) total score from baseline [ Time Frame: followed up to 4,8,12 weeks from baseline ] [ Designated as safety issue: No ]
  • Changes in Raven Progressive Matrices(RPM) total score from baseline [ Time Frame: followed up to 4,8,12 weeks from baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01309776 on ClinicalTrials.gov Archive Site
  • Changes in Hamilton Rating Scale for Anxiety(HAM-A) score from baseline [ Time Frame: followed to 2,4,8,12 weeks from baseline ] [ Designated as safety issue: No ]
  • Changes in Clinical Clinical Global Impression- improvement(CGI-I) [ Time Frame: followed to 2,4,8,12 weeks from baseline ] [ Designated as safety issue: No ]
  • Change in Response Rate from baseline [ Time Frame: followed to 12 weeks from baseline ] [ Designated as safety issue: No ]
  • Change in Mini-Mental status examination(MMSE) total score from baseline [ Time Frame: followed to 4,8,12 weeks from baseline ] [ Designated as safety issue: No ]
  • Change in Sexual Function Scale [ Time Frame: followed to 2,4,8,12 weeks from baseline ] [ Designated as safety issue: Yes ]
  • Change in Clinical Global Impression- severity(CGI-S) [ Time Frame: followed to 2,4,8,12 weeks from baseline ] [ Designated as safety issue: No ]
  • Change in Remission Rate from baseline [ Time Frame: followed to 12 weeks from baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Tianeptine
    week1 : 25mg/day q.d., week2: 37.5mg/day b.i.d. (12.5mg 1T, 12.5mg 2T
    Other Name: Stablon
  • Drug: Escitalopram
    week1 : 5mg/day q.d., week2: 10mg/day q.d.
  • Experimental: Tianeptine
    Intervention: Drug: Tianeptine
  • Active Comparator: Escitalopram
    Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
164
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01309776
2010-11-029
No
Bum-Hee Yu, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Bum Hee Yu, Ph.D. Department of Pyschiatry, Sansung Medical Center
Samsung Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP