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Trial record 6 of 724 for:    pharmacogenomics OR pharmacogenetics
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Pharmacogenomics Studies of Antidepressants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Cheng-Kung University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01204086
First received: September 15, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • C-reactive Protein and IL-6 [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • fasting blood glucose, lipid profiles [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • C-reactive Protein and IL-6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • fasting blood glucose, lipid profiles [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 15, 2010
Last Updated: September 15, 2010
Health Authority: Taiwan: Institutional Review Board

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
Psychotropic Drugs
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on May 22, 2013