NCT00817011

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

10.7 years

First QC Date

January 5, 2009

Last Update Submit

December 30, 2015

Conditions

DepressionAntidepressant Drug Adverse Reaction

Keywords

depressionpharmacogenomicsantidepressant responsebiological markersclinical variables

Outcome Measures

Primary Outcomes (1)

  • all pharmacogenetic and biological marker variables cause drug response

    24weeks

Secondary Outcomes (1)

  • all clinical cause drug response

    24weeks

Study Arms (2)

SSRI treated group

EXPERIMENTAL

SSRI treated group are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline

Drug: SSRI treated group

non-SSRI treated group

ACTIVE COMPARATOR

non-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine

Drug: non-SSRI treated group

Interventions

SSRI treated groupDRUG

Antidepressant administration of SSRI class for 6 weeks under therapeutic dose

Also known as: Other Names:, fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, citalopram_Celexa
SSRI treated group
non-SSRI treated groupDRUG

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

Also known as: venlafaxine_Effexor, nortriptyline_Aventyl, Pamelor, Noritren, mirtazapine_Avanza, Zispin, Remeron, bupropion_amfebutamone, Wellbutrin, Zyban, duloxetine_Cymbalta, Yentreve, trazodone_Desyrel, Beneficat, Deprax
non-SSRI treated group

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \< age \<85
  • major depressed patients satisfied with the diagnosis criteria depression of DSM-IV
  • 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, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

ParoxetineNortriptylineMirtazapineBupropionDuloxetine HydrochlorideTrazodone

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingPropiophenonesKetonesThiophenesSulfur CompoundsPiperazinesPyridonesPyridines

Study Officials

  • Doh Kwan Kim, M.D.,Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doh Kwan Kim, M.D.,Ph.D

CONTACT

82-2-3410-0946jungshil.back@sbri.co.kr

Shinn-Won Lim, phD

CONTACT

82-2-3410-3759shinwon.lim@sbri.co.kr

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

January 5, 2009

First Posted

January 6, 2009

Study Start

April 1, 2006

Primary Completion

December 1, 2016

Study Completion

March 1, 2018

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations

KR(1)