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Major Depressive DisorderPhase 4CAMPIONNCT01309776

Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder

A Phase 4 study testing Tianeptine and Escitalopram in people with Major Depressive Disorder, run by Samsung Medical Center at 6 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
Tianeptine and Escitalopram
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
6 sitesSouth Korea
Study dates
Mar 2011to Sep 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites

  • Inje University Paik Hospital

    Goyang, 411-706

  • Inje University Seoul Paik Hospital

    Seoul, 100-032

  • Asan Medical Center

    Seoul

  • Eulji Medical College Hospital

    Seoul

  • Konkuk University Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Tianeptine, Escitalopram
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TianeptineDrug

    Also called Stablon

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

  • EscitalopramDrug

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

Study groups in NCT01309776
Study groupRoleWhat they receive
TianeptineExperimentalNot described
Receives: Drug: Tianeptine
EscitalopramActive comparatorNot described
Receives: Drug: Escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

    Measured: followed up to 4,8,12 weeks from baseline

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

    Measured: followed up to 4,8,12 weeks from baseline

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

    Measured: followed up to 4,8,12 weeks from baseline

Secondary outcomes (7)

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

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

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

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

  3. Change in Response Rate from baseline

    Measured: followed to 12 weeks from baseline

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

    Measured: followed to 4,8,12 weeks from baseline

  5. Change in Sexual Function Scale

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

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

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

  7. Change in Remission Rate from baseline

    Measured: followed to 12 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309776
Sponsor's protocol ID
2010-11-029
Acronym
CAMPION
Status last verified
Jan 2013
First submitted
2 Mar 2011
Last updated
25 Jan 2013
Results posted
No
Data monitoring committee
No

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.

    PubMed 26142691

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tianeptine and Escitalopram in people with Major Depressive Disorder, run by Samsung Medical Center at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01309776, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2013.

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