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

Major Depressive Disorder Clinical Trial

Official title:

A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00926835
• Other study ID #: MIHWAF-CRCD-K-01
• Status: Terminated
• Phase: Phase 4
• First received: June 23, 2009
• Last updated: September 1, 2015
• Start date: May 2009
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Ministry of Health & Welfare, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will be classified into 3 levels by their past therapeutic histories:

Level 1: Patients who do not receive an appropriate treatment for their current major depressive episode.

Level 2: Patients who never showed a satisfactory response to an adequate dosage of Paroxetine during a sufficient period of their current major depressive episode.

Level 3: Patients without a satisfactory response to two or more antidepressants including one of Paroxetine or Escitalopram for a sufficient period.

A satisfactory response means baseline HAM-D17 score was reduced over 50% or HAM-D17 score 10 or below and a sufficient period means 6 weeks.

Patients will be randomly assigned to the following treatment groups. Patients in level 1 will be randomly assigned to treatment groups among Paroxetine monotherapy, Escitalopram monotherapy, or Venlafaxine monotherapy.

Patients in level 2 will be enrolled who were medicated Paroxetine monotherapy in level 1 and assigned to one of the following 4 groups; Escitalopram monotherapy, Venlafaxine monotherapy, Paroxetine combined with Venlafaxine, or Paroxetine augmented with Lithium.

Patients in level 3 will be randomly assigned to one of the following 4 groups: 1) Either Paroxetine combined with Lamotrigine or Paroxetine combined with Bupropion if they resist two antidepressants including Paroxetine. 2) Either Escitalopram combined with Mirtazapine or Escitalopram combined with Aripiprazole if they resist two antidepressants including Escitalopram. 3) Patients who does not respond to both Paroxetine and Escitalopram will be randomly assigned to either 1) or 2).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 692
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• paroxetine
6 weeks, 20-50mg/day
• Escitalopram
10-20mg/day for 6 weeks
• Venlafaxine XR
Venlafaxine 75-225mg/day for 6 weeks
• Paroxetine+Bupropion
paroxetine 20-50mg/day + bupropion 150-400mg/day for 6 weeks
• Paroxetine+Lamotrigine
Paroxetine 20-50mg/day + lamotrigine 100-400mg/day for 6 weeks
• Paroxetine+Lithium
Paroxetine 20-50mg/day + lithium 0.5-1.2 mEq/L
• Escitalopram+Mirtazapine
escitalopram 10-20mg/day + mirtazapine 15-45mg/day for 6 weeks
• Escitalopram+Aripiprazole
escitalopram 10-20mg/day + aripiprazole 5-15mg/day for 6 weeks
• Paroxetine + Venlafaxine XR
Paroxetine 20-50mg/day + Venlafaxine 75-225mg/day for 6 weeks

Locations

Country	Name	City	State
Korea, Republic of	Clinical research center for depression	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale		6 week	No