NCT01352559

Brief Summary

The purpose of this study is to determine whether pharmacogenomic study of bioamine transporters and peripheral lymphatic biomarkers(phenotype) predict antidepressant responsiveness in advance before the appearance of the drug effects until 4\~6 weeks after drug administration.

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 Nov 2001

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

November 1, 2001

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

5.3 years

First QC Date

April 21, 2011

Last Update Submit

December 30, 2015

Conditions

Depression

Keywords

PharmacogenomicsPrediction of Antidepressant ResponseDepressed PatientsbiomarkersphenotypeAntidepressant ResponseAdverse Reaction to Drug

Outcome Measures

Primary Outcomes (1)

  • Antidepressant Response at 6 weeks

    antidepressant response is defined as the decrease rate of HAM-D score for 6week was = or \> 50% Measurement Unit = responders, nonresponders

    6 weeks

Secondary Outcomes (1)

  • Biological value at 0 and 6 weeks

    6 weeks

Study Arms (2)

responders

EXPERIMENTAL

50 ≤ Decrease rate(%) of HAM-D score

Drug: responders

non-responders

ACTIVE COMPARATOR

nonresponders is a patients having 50 \> Decrease rate(%) of HAM-D score

Drug: non-responders

Interventions

respondersDRUG

Antidepressants administration for 6 weeks under therapeutic dose

Also known as: fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, milnacipran, venlafaxine_Effexor, nortriptyline_Aventyl, Pamelor, Noritren, mirtazapine_Avanza, Zispin, Remeron
responders
non-respondersDRUG

Antidepressants administration for 6 weeks under therapeutic dose

Also known as: SSRI nonresponders
non-responders

Eligibility Criteria

Age19 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Kangnam, Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

DepressionDrug-Related Side Effects and Adverse Reactions

Interventions

ParoxetineMilnacipranNortriptylineMirtazapine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclopropanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Doh Kwan Kim, M.D., Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 21, 2011

First Posted

May 12, 2011

Study Start

November 1, 2001

Primary Completion

March 1, 2007

Study Completion

December 1, 2018

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations

KR(1)