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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Tianeptine

Escitalopram

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Inje University Paik Hospital
Inje University Seoul Paik Hospital
Asan Medical Center
Eulji Medical College Hospital
Konkuk University Medical Center
Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tianeptine

Escitalopram

Arm Description

Outcomes

Primary Outcome Measures

Changes in Hamilton Rating Scale for Depression(HAM-D)score from baseline

Changes in Korean version-California Verbal Learnign Test(K-CVLT) total score from baseline

Changes in Visual Continuous Performance Test(CPT) total score from baseline

Changes in Raven Progressive Matrices(RPM) total score from baseline

Secondary Outcome Measures

Changes in Hamilton Rating Scale for Anxiety(HAM-A) score from baseline

Changes in Clinical Clinical Global Impression- improvement(CGI-I)

Change in Response Rate from baseline

Change in Mini-Mental status examination(MMSE) total score from baseline

Change in Sexual Function Scale

Change in Clinical Global Impression- severity(CGI-S)

Change in Remission Rate from baseline

Full Information

NCT ID

NCT01309776

First Posted

March 2, 2011

Last Updated

January 24, 2013

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01309776

Brief Title

Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder

Acronym

CAMPION

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

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

164 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tianeptine

Arm Type

Experimental

Arm Title

Escitalopram

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tianeptine

Other Intervention Name(s)

Stablon

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in Hamilton Rating Scale for Depression(HAM-D)score from baseline

Time Frame

followed up to 2,4,8,12 weeks from baseline

Title

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

Title

Changes in Visual Continuous Performance Test(CPT) total score from baseline

Time Frame

followed up to 4,8,12 weeks from baseline

Title

Changes in Raven Progressive Matrices(RPM) total score from baseline

Time Frame

followed up to 4,8,12 weeks from baseline

Secondary Outcome Measure Information:

Title

Changes in Hamilton Rating Scale for Anxiety(HAM-A) score from baseline

Time Frame

followed to 2,4,8,12 weeks from baseline

Title

Changes in Clinical Clinical Global Impression- improvement(CGI-I)

Time Frame

followed to 2,4,8,12 weeks from baseline

Title

Change in Response Rate from baseline

Time Frame

followed to 12 weeks from baseline

Title

Change in Mini-Mental status examination(MMSE) total score from baseline

Time Frame

followed to 4,8,12 weeks from baseline

Title

Change in Sexual Function Scale

Time Frame

followed to 2,4,8,12 weeks from baseline

Title

Change in Clinical Global Impression- severity(CGI-S)

Time Frame

followed to 2,4,8,12 weeks from baseline

Title

Change in Remission Rate from baseline

Time Frame

followed to 12 weeks from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bum Hee Yu, Ph.D.

Organizational Affiliation

Department of Pyschiatry, Sansung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inje University Paik Hospital

City

Goyang

ZIP/Postal Code

411-706

Country

Korea, Republic of

Facility Name

Inje University Seoul Paik Hospital

City

Seoul

ZIP/Postal Code

100-032

Country

Korea, Republic of

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Eulji Medical College Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Konkuk University Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26142691

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.

Results Reference

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Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder

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