Skip to content

Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00817011
Acronym
PG
Enrollment
1000
Registered
2009-01-06
Start date
2006-04-30
Completion date
2018-03-31
Last updated
2015-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antidepressant Drug Adverse Reaction, Depression

Keywords

depression, pharmacogenomics, antidepressant response, biological markers, clinical variables

Brief summary

The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.

Detailed description

The difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) The time lag is existed until the patients respond to antidepressant and show the treatment effects. If it is predicted the response of antidepressant in advance, it would be overcome such problems. Drug response generally is known to be related to the individual genetic information and the environmental factors. We are going to investigation about antidepressant response using these approaches.

Interventions

Antidepressant administration of SSRI class for 6 weeks under therapeutic dose

Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

1. 25 \< age \<85 2. major depressed patients satisfied with the diagnosis criteria depression of DSM-IV 3. 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.

Design outcomes

Primary

MeasureTime frame
all pharmacogenetic and biological marker variables cause drug response24weeks

Secondary

MeasureTime frame
all clinical cause drug response24weeks

Countries

South Korea

Contacts

Primary ContactDoh Kwan Kim, M.D.,Ph.D
jungshil.back@sbri.co.kr82-2-3410-0946
Backup ContactShinn-Won Lim, phD
shinwon.lim@sbri.co.kr82-2-3410-3759

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026