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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Tianeptine; Drug: Escitalopram

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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Goyang, Korea, Republic of, 411-706
    • Inje University Paik Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 100-032
    • Inje University Seoul Paik Hospital
  • Seoul, Korea, Republic of
    • Eulji Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Escitalopram	Drug: Escitalopram; week1 : 5mg/day q.d., week2: 10mg/day q.d.
Experimental: Tianeptine	Drug: Tianeptine; week1 : 25mg/day q.d., week2: 37.5mg/day b.i.d. (12.5mg 1T, 12.5mg 2T; Other Names: Stablon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Change in Clinical Global Impression- severity(CGI-S)	followed to 2,4,8,12 weeks from baseline
Change in Remission Rate from baseline	followed to 12 weeks from baseline

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Bum Hee Yu, Ph.D., Department of Pyschiatry, Sansung Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 2, 2011
• First Submitted That Met QC Criteria: March 4, 2011
• First Posted (Estimate): March 7, 2011

Study Record Updates

• Last Update Posted (Estimate): January 25, 2013
• Last Update Submitted That Met QC Criteria: January 24, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antidepressive Agents, Tricyclic; Citalopram; Tianeptine
• Other Study ID Numbers: 2010-11-029