Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309776
• Other study ID #: 2010-11-029
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2011
• Last updated: January 24, 2013
• Start date: March 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Tianeptine
week1 : 25mg/day q.d., week2: 37.5mg/day b.i.d. (12.5mg 1T, 12.5mg 2T
• Escitalopram
week1 : 5mg/day q.d., week2: 10mg/day q.d.

Locations

Country	Name	City	State
Korea, Republic of	Inje University Paik Hospital	Goyang
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Eulji Medical College Hospital	Seoul
Korea, Republic of	Inje University Seoul Paik Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Hamilton Rating Scale for Depression(HAM-D)score from baseline		followed up to 2,4,8,12 weeks from baseline	No
Primary	Changes in Korean version-California Verbal Learnign Test(K-CVLT) total score from baseline		followed up to 4,8,12 weeks from baseline	No
Primary	Changes in Visual Continuous Performance Test(CPT) total score from baseline		followed up to 4,8,12 weeks from baseline	No
Primary	Changes in Raven Progressive Matrices(RPM) total score from baseline		followed up to 4,8,12 weeks from baseline	No
Secondary	Changes in Hamilton Rating Scale for Anxiety(HAM-A) score from baseline		followed to 2,4,8,12 weeks from baseline	No
Secondary	Changes in Clinical Clinical Global Impression- improvement(CGI-I)		followed to 2,4,8,12 weeks from baseline	No
Secondary	Change in Response Rate from baseline		followed to 12 weeks from baseline	No
Secondary	Change in Mini-Mental status examination(MMSE) total score from baseline		followed to 4,8,12 weeks from baseline	No
Secondary	Change in Sexual Function Scale		followed to 2,4,8,12 weeks from baseline	Yes
Secondary	Change in Clinical Global Impression- severity(CGI-S)		followed to 2,4,8,12 weeks from baseline	No
Secondary	Change in Remission Rate from baseline		followed to 12 weeks from baseline	No