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Major Depressive Disorder | Pharmacogenomics Studies of Antidepressants

Major Depressive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Antidepressive Agents

Pharmacogenetics

Venlafaxine

Fluoxetine

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:VenlafaxineThe 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.

Drug:FluoxetineThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

venlafaxine

fluoxetine

Study Status

Unknown status

Start Date: March 2007

Completed Date: February 2011

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Hamilton Depression Rating Scale (HDRS)

Secondary Outcome: C-reactive Protein and IL-6

Study sponsors, principal investigator, and references

Principal Investigator: Po See Chen, MD

Lead Sponsor: National Cheng-Kung University Hospital

Collaborator: Department of Health, Executive Yuan, R.O.C. (Taiwan)

More information:https://clinicaltrials.gov/show/NCT01204086

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