NCT01352572

Brief Summary

The purpose of this study is to determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4\~6 weeks after drug administration, or represent the clinical status of 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
300

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2002

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

January 1, 2002

Completed
9.3 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

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day 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

16.9 years

First QC Date

April 21, 2011

Last Update Submit

December 30, 2015

Conditions

Depression

Keywords

Antidepressant ResponseSignal TransductionLymphocyteBiomarkersDepressed PatientsAntidepressant Drug Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • Antidepressant Response at 6 weeks

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

    6 weeks

Secondary Outcomes (1)

  • Biological value at 0 and 6 weeks

    6 weeks

Study Arms (2)

antidepressant response

EXPERIMENTAL

antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score

Drug: antidepressant response

antidepressant non-response

ACTIVE COMPARATOR

antidepressant non-response are refered the patients having a 50 \> Decrease rate(%) of HAM-D score

Drug: antidepressant non-response

Interventions

antidepressant responseDRUG

Antidepressants administration for 6 weeks under therapeutic dose responders

Also known as: fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, milnacipran, venlafaxine_Effexor, nortriptyline_Aventyl, Pamelor, Noritren, mirtazapine_Avanza, Zispin, Remeron
antidepressant response
antidepressant non-responseDRUG

Antidepressants administration for 6 weeks under therapeutic dose nonresponders

Also known as: fluoxetine, paroxetine, sertraline, milnacipran, venlafaxine, nortriptyline, mirtazapine
antidepressant non-response

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea.
  • were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents

You may not qualify if:

  • pregnancy
  • significant medical conditions
  • abnormal laboratory baseline values
  • unstable psychiatric features (e.g, suicidal attempt)
  • history of alcohol or drug dependence, seizure, 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

Depression

Interventions

ParoxetineMilnacipranNortriptylineMirtazapineFluoxetineSertralineVenlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclopropanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingPropylaminesAmines1-NaphthylamineNaphthalenesCyclohexanolsHexanolsFatty AlcoholsAlcoholsPhenethylaminesEthylaminesCyclohexanesLipids

Study Officials

  • Doh Kwan Kim, MD PhD

    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

January 1, 2002

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations

KR(1)