Predict Antidepressant Responsiveness Using Pharmacogenomics
1 other identifier
interventional
1,000
1 country
1
Brief Summary
The purpose of this study is to determine whether genetic information associated with individual depressive symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Feb 2003
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 24, 2010
CompletedFirst Posted
Study publicly available on registry
October 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedDecember 31, 2015
December 1, 2015
15.8 years
October 24, 2010
December 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presences of each individual symptom of depression at 1,2,4,6,12 weeks
17-items HAM-D scale was employed to measure depressive symptoms
12 weeks
Study Arms (2)
SSRI treated group
EXPERIMENTALSSRI treated group is patients treated with fluoxetine, paroxetine, or sertraline
non-SSRI treated group
ACTIVE COMPARATORnon-SSRI treated group is patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine
Interventions
Antidepressant administration of SSRI class for 12 weeks under therapeutic dose
Antidepressant administration of non-SSRI class for 12 weeks under therapeutic dose
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Kangnam, Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Doh Kwan Kim, M.D., Ph.D.
Samsung Medical Center
Central Study Contacts
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
October 24, 2010
First Posted
October 26, 2010
Study Start
February 1, 2003
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
December 31, 2015
Record last verified: 2015-12