Pharmacogenomics Studies of Antidepressants

Major Depressive Disorder Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01204086
• Other study ID #: HR-95-06
• Secondary ID: DOH96-TD-D-113-0
• Status: Recruiting
• Phase: Phase 4
• First received: September 15, 2010
• Last updated: September 15, 2010
• Start date: March 2007
• Est. completion date: February 2011

Study information

• Verified date: September 2010
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to establish the clinical effectiveness of antidepressants by pharmacogenomic approach, and to determine the levels of inflammatory factors between the baseline and the end point of the study in Taiwanese major depressive disorder (MDD) patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age: 16-65 years old

• Signed informed consent by patient or legal representative

• Hamilton Rating Scale for Depression (HDRS) scores = 16

• A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry

Exclusion Criteria:

• monoamine oxidase inhibitor or antidepressant treatment within two weeks prior to entering the study

• A DSM-IV diagnosis of substance abuse within the past three months

• An organic mental disease, mental retardation or dementia

• A serious surgical condition or physical illness

• Patients who were pregnant or breastfeeding

Study Design

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

Related Conditions & MeSH terms

• Antidepressive Agents
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Fluoxetine
• Major Depressive Disorder
• Pharmacogenetics
• Venlafaxine

Intervention

Drug:
• Venlafaxine
The initial dose of venlafaxine was 37.5 mg once daily for 4 days titrated to 75 mg once daily, which could be increased by 75 mg in divided doses to a maximal daily dose of 225 mg.
• Fluoxetine
The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 80 mg.

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HDRS)		baseline	No
Primary	Hamilton Depression Rating Scale (HDRS)		2 weeks	No
Primary	Hamilton Depression Rating Scale (HDRS)		4 weeks	No
Primary	Hamilton Depression Rating Scale (HDRS)		6 weeks	No
Secondary	C-reactive Protein and IL-6		baseline	No
Secondary	fasting blood glucose, lipid profiles		baseline	No
Secondary	C-reactive Protein and IL-6		6 weeks	No
Secondary	fasting blood glucose, lipid profiles		6 weeks	No