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Pharmacogenomics Studies of Antidepressants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01204086
First Posted: September 17, 2010
Last Update Posted: September 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
National Cheng-Kung University Hospital
  Purpose
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.

Condition Intervention Phase
Major Depressive Disorder Antidepressive Agents Pharmacogenetics Venlafaxine Fluoxetine Drug: Venlafaxine Drug: Fluoxetine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: baseline ]
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: 2 weeks ]
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: 4 weeks ]
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • C-reactive Protein and IL-6 [ Time Frame: baseline ]
  • fasting blood glucose, lipid profiles [ Time Frame: baseline ]
  • C-reactive Protein and IL-6 [ Time Frame: 6 weeks ]
  • fasting blood glucose, lipid profiles [ Time Frame: 6 weeks ]

Estimated Enrollment: 200
Study Start Date: March 2007
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: venlafaxine 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.
Experimental: fluoxetine Drug: 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204086


Locations
Taiwan
National Cheng-Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Po See Chen, MD    +886-6-2353535 ext 5213    chenps@mail.ncku.edu.tw   
Principal Investigator: Po See Chen, MD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Investigators
Principal Investigator: Po See Chen, MD National Cheng-Kung University Hospital
  More Information

Responsible Party: Po See Chen/ MD, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01204086     History of Changes
Other Study ID Numbers: HR-95-06
DOH96-TD-D-113-041 ( Other Grant/Funding Number: Department of Health, Taiwan )
First Submitted: September 15, 2010
First Posted: September 17, 2010
Last Update Posted: September 17, 2010
Last Verified: September 2010

Keywords provided by National Cheng-Kung University Hospital:
Major Depressive Disorder
Antidepressants
Pharmacogenetics
venlafaxine
fluoxetine

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Fluoxetine
Venlafaxine Hydrochloride
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors