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

NCT00935246 | Unknown DMC

• 1 other identifier: 2008-12-042
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression; Continuous Antidepressant Abuse; Adverse Reaction to Drug

Keywords

Genomic devices; Prediction of Escitalopram Response; Depressed Patients

Outcome Measures

Primary Outcomes (1)

• antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks

  8 weeks

Secondary Outcomes (1)

• biological value at 0 week and 8 weeks

  8 weeks

Study Arms (2)

Antidepressant treated group

EXPERIMENTAL

Antidepressant treated group: depressed patients treated with Escitalopram

Drug: Escitalopram

other antidepressant treated group

NO INTERVENTION

other Antidepressant treated group: depressed patients treated with other antidepressant without escitalopram

Interventions

Escitalopram DRUG

Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose

Also known as: Escitalopram : Lexapro

Antidepressant treated group

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

You may not qualify if:

• received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Samsung Medical Center

Kangnam, Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Depression; Drug-Related Side Effects and Adverse Reactions

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Doh Kwan Kim, PhD, M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: December 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2016
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

KR (1)