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

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

Study Overview

• Status: Unknown
• Conditions: Depression; Adverse Reaction to Drug; Continuous Antidepressant Abuse
• Intervention / Treatment: Drug: Escitalopram

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
• Enrollment (Anticipated): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Kangnam, Seoul, Korea, Republic of, 135-710
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Escitalopram : Lexapro
NO_INTERVENTION: other antidepressant treated group; other Antidepressant treated group: depressed patients treated with other antidepressant without escitalopram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
biological value at 0 week and 8 weeks	8 weeks

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (ESTIMATE): July 8, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Genomic devices; Prediction of Escitalopram Response; Depressed Patients
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Dexetimide
• Other Study ID Numbers: 2008-12-042