Comparison of Tianeptine Versus Escitalopram Patients Major Depressive Disorder (CAMPION)
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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 |
- 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 ]
- 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 |
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
Contacts and 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 | |
| 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 Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents Antidepressive Agents, Tricyclic |
ClinicalTrials.gov processed this record on May 21, 2013