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Pharmacogenomics Studies of Antidepressants

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01204086
Enrollment
200
Registered
2010-09-17
Start date
2007-03-31
Completion date
2011-02-28
Last updated
2010-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Major Depressive Disorder, Antidepressants, Pharmacogenetics, venlafaxine, fluoxetine

Brief 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.

Interventions

DRUGVenlafaxine

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.

DRUGFluoxetine

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale (HDRS)baseline

Secondary

MeasureTime frame
fasting blood glucose, lipid profilesbaseline
C-reactive Protein and IL-6baseline

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026