Overview

This trial is active, not recruiting.

Conditions depression, continuous antidepressant abuse, adverse reaction to drug
Treatment escitalopram
Sponsor Samsung Medical Center
Collaborator H. Lundbeck A/S
Start date December 2008
End date October 2011
Trial size 202 participants
Trial identifier NCT00935246, 2008-12-042

Summary

To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Antidepressant treated group: depressed patients treated with Escitalopram
escitalopram Escitalopram : Lexapro
Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose
(No Intervention)
other Antidepressant treated group: depressed patients treated with other antidepressant without escitalopram

Primary Outcomes

Measure
antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks
time frame: 8 weeks

Secondary Outcomes

Measure
biological value at 0 week and 8 weeks
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 19 years up to 89 years old.

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.

Additional Information

Official title Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning
Principal investigator Doh Kwan Kim, PhD, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Samsung Medical Center.