Overview

Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients

Status:
Terminated
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
All
Summary
The primary purpose of this study is to investigate the effectiveness of antidepressants on the treatments for non-psychotic major depressive disorder (MDD) in Korea. The study divides MDD patients into 3 level groups according to their past histories to treatments and compares the effectiveness of various treatment regimens at each level. The treatment level groups are: 1) patients who have never been treated with appropriate medications for their current depressive symptoms before, 2) who received an appropriate SSRI (Selective Serotonin Reuptake Inhibitor) once but did not respond to it, 3) who received two types of SSRI antidepressant treatments without much effects in reducing their depressive symptoms. The first level group will be treated with a single SSRI antidepressant treatment. The second and third level groups, who received SSRI treatment before, will be treated with alternative SSRI antidepressants (switching), combined multiple SSRI treatments (antidepressant combination), or SSRI treatments combined with mood stabilizer or anti-psychotics (augmentation). This study does not use placebos. Patients will visit 5 times for 6 weeks at each level for treatments. Patients will be evaluated for the severity of depressive symptoms, functional level, and side effects at each visit. Afterwards, the investigations will combine to monitor the patients depressive symptoms in every 3 months for the next 24 months. 18 nationwide university hospitals will participate in this study. This multi-site, prospective, and naturalistic study for patients with depression in Korea is a main project of 'Clinical Research Center for Depression' funded by the Ministry for Health, Welfare, and Family Affairs (MIHWAF) in Korea for a highly-qualified research achievement.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ministry of Health & Welfare, Korea
Treatments:
Anticonvulsants
Antidepressive Agents
Aripiprazole
Bupropion
Citalopram
Dexetimide
Lamotrigine
Lithium Carbonate
Mianserin
Mirtazapine
Paroxetine
Venlafaxine Hydrochloride
Criteria
Inclusion Criteria:

- Clinical diagnosis of non-psychotic Major depressive disorder

- HAMD-17 score 14 or greater

- Age of 18 or greater and 65 or less

Exclusion Criteria:

- patients with current or past history of diagnosis of bipolar disorder, schizophrenia,
schizoaffective disorder, or psychotic disorder NOS

- patients with current psychotic features, eating disorders or obsessive-compulsive
disorder

- patients with neurological disorder

- patients with medical condition that could interfere with everyday life activities

- pregnant or lactating women,

- patients with current other DSM-IV TR Axis I diagnosis other than MDD which needs
inpatient care

- patients who treated with ECT for current depressive episode

- insufficient information of past treatment for current depressive episode

- patients who posed a serious suicidal risk.