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Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning

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ClinicalTrials.gov Identifier: NCT00935246
Recruitment Status : Unknown
Verified December 2015 by Doh Kwan Kim, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : July 8, 2009
Last Update Posted : December 31, 2015
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE July 7, 2009
First Posted Date  ICMJE July 8, 2009
Last Update Posted Date December 31, 2015
Study Start Date  ICMJE December 2008
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00935246 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
biological value at 0 week and 8 weeks [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning
Official Title  ICMJE Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning
Brief Summary To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning).
Detailed Description

The purposes of this study are:

  1. To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning)
  2. To improve the success rate of escitalopram treatment response for depressed patients
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Continuous Antidepressant Abuse
  • Adverse Reaction to Drug
Intervention  ICMJE Drug: Escitalopram
Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose
Other Name: Escitalopram : Lexapro
Study Arms  ICMJE
  • Experimental: Antidepressant treated group
    Antidepressant treated group: depressed patients treated with Escitalopram
    Intervention: Drug: Escitalopram
  • No Intervention: other antidepressant treated group
    other Antidepressant treated group: depressed patients treated with other antidepressant without escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 7, 2009)
202
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
  2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

  1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
  2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00935246
Other Study ID Numbers  ICMJE 2008-12-042
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Doh Kwan Kim, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE
Principal Investigator: Doh Kwan Kim, PhD, M.D. Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP