Phase
Condition
Depression
Affective Disorders
Depression (Major/severe)
Treatment
N/AClinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thisclinical study
Women of childbearing potential with negative pregnancy test during screening phaseand entire study period (during entire study period, able to clearly agree witheffective contraception such as contraceptive pill, progesterone injection,levonorgestrel implant, estrogen ring, transdermal contraceptive agent, intra-uterinecontraceptive device, sterilization operation of husband, and double contraceptivemethod (e.g. combination of condom, pessary, spermicide, etc. ))
Patients who have subjective cognitive impairment, or who have objective cognitiveimpairment (MMSE ≤26) without subjective cognitive impairment
HAM-D(17-items) total score ≥ 16
Exclusion
Exclusion Criteria:
Patients meeting more than one following patient characteristics
Patients fulfilling DSM-IV-TR current or past diagnosis of any psychiatricdisorders other than major depressive disorder (i.e. manic or hypomanic episode,schizophrenia, delirium, dementia, eating disorder, obsessive-compulsivedisorder, panic disorder, post-traumatic stress disorder, major depressivedisorder with psychotic features, mental retardation, organic brain disorder, orpsychiatric 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. multiplesclerosis, seizure, etc.)
Patients with any axis II disorder that prone to interfere with the evaluation ofthe 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 forgetting psychotherapy
Patients with any clinically significant abnormality (e.g. hepatic failure, renalfailure, cardiovascular disorder, respiratory disorder, gastrointestinal disorder,endocrine disorder, neurological disorder, inflammatory disorder, neoplasm, metabolicdisorder, etc.)
Patients who have abnormal ECG and a significant disease according to theinvestigator'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 ofmajor depressive disorder
Patients who have a suicide risk according to the investigator's judgment
Study Design
Study Description
Connect with a study center
Inje University Paik Hospital
Goyang, 411-706
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul,
Korea, Republic ofSite Not Available
Eulji Medical College Hospital
Seoul,
Korea, Republic ofSite Not Available
Inje University Seoul Paik Hospital
Seoul, 100-032
Korea, Republic ofSite Not Available
Konkuk University Medical Center
Seoul,
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul,
Korea, Republic ofSite Not Available
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