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

• ClinicalTrials.gov Identifier: NCT00935246
• Recruitment Status: Unknown
• First Posted: July 8, 2009
• Last Update Posted: December 31, 2015
• Sponsor: Samsung Medical Center
• Collaborator: H. Lundbeck A/S
• Information provided by (Responsible Party): Doh Kwan Kim, Samsung Medical Center

Tracking Information

• First Submitted Date: July 7, 2009
• First Posted Date: July 8, 2009
• Last Update Posted Date: December 31, 2015
• Study Start Date: December 2008
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: July 7, 2009): biological value at 0 week and 8 weeks [ Time Frame: 8 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Depression
• Continuous Antidepressant Abuse
• Adverse Reaction to Drug

Intervention

Drug: Escitalopram

Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose

Other Name: Escitalopram : Lexapro

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 7, 2009): 202
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2016
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 19 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00935246
• Other Study ID Numbers: 2008-12-042
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Doh Kwan Kim, Samsung Medical Center
• Study Sponsor: Samsung Medical Center
• Collaborators: H. Lundbeck A/S

Investigators

• Principal Investigator: Doh Kwan Kim, PhD, M.D.; Samsung Medical Center

• PRS Account: Samsung Medical Center
• Verification Date: December 2015