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Trial record 22 of 631 for:    ESCITALOPRAM
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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Depression Continuous Antidepressant Abuse Adverse Reaction to Drug Drug: Escitalopram Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning
Study Start Date : December 2008
Actual Primary Completion Date : October 2011
Estimated Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Antidepressant treated group
Antidepressant treated group: depressed patients treated with Escitalopram
 Drug: Escitalopram
Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose
Other Name: Escitalopram : Lexapro
No Intervention: other antidepressant treated group
other Antidepressant treated group: depressed patients treated with other antidepressant without escitalopram


Outcome Measures
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Primary Outcome Measures :
  1. antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. biological value at 0 week and 8 weeks [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT00935246


Locations
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Korea, Republic of
Samsung Medical Center
Kangnam, Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
H. Lundbeck A/S
Investigators
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Principal Investigator: Doh Kwan Kim, PhD, M.D. Samsung Medical Center
More Information
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Responsible Party: Doh Kwan Kim, M.D., Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00935246    
Other Study ID Numbers: 2008-12-042
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015
Keywords provided by Doh Kwan Kim, Samsung Medical Center:
Genomic devices
Prediction of Escitalopram Response
Depressed Patients
Additional relevant MeSH terms:
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Dexetimide
Citalopram
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
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
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents