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
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Tianeptine
Drug: Escitalopram
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 164
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tianeptine Drug: Tianeptine
week1 : 25mg/day q.d., week2: 37.5mg/day b.i.d. (12.5mg 1T, 12.5mg 2T
Other Name: Stablon
Active Comparator: Escitalopram Drug: Escitalopram
week1 : 5mg/day q.d., week2: 10mg/day q.d.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309776

Locations
Korea, Republic of
Inje University Paik Hospital
Goyang, Korea, Republic of, 411-706
Inje University Seoul Paik Hospital
Seoul, Korea, Republic of, 100-032
Konkuk University Medical Center
Seoul, Korea, Republic of
Eulji Medical College Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Bum Hee Yu, Ph.D. Department of Pyschiatry, Sansung Medical Center
  More Information

No publications provided

Responsible Party: Bum-Hee Yu, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01309776     History of Changes
Other Study ID Numbers: 2010-11-029
Study First Received: March 2, 2011
Last Updated: January 24, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Tianeptine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antidepressive Agents, Tricyclic

ClinicalTrials.gov processed this record on August 28, 2014