MedDataX Logo

Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

NCT ID: NCT01352572

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Antidepressant Response Signal Transduction Lymphocyte Biomarkers Depressed Patients Antidepressant Drug Adverse Reaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

antidepressant response

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

Group Type EXPERIMENTAL

antidepressant response

Intervention Type DRUG

Antidepressants administration for 6 weeks under therapeutic dose responders

antidepressant non-response

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

Group Type ACTIVE_COMPARATOR

antidepressant non-response

Intervention Type DRUG

Antidepressants administration for 6 weeks under therapeutic dose nonresponders

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

antidepressant response

Antidepressants administration for 6 weeks under therapeutic dose responders

Intervention Type DRUG

antidepressant non-response

Antidepressants administration for 6 weeks under therapeutic dose nonresponders

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

fluoxetine_Prozac paroxetine_Paxil, Seroxat sertraline_Zoloft milnacipran venlafaxine_Effexor nortriptyline_Aventyl, Pamelor, Noritren mirtazapine_Avanza, Zispin, Remeron fluoxetine, paroxetine, sertraline milnacipran, venlafaxine, nortriptyline, mirtazapine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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.
2. 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Doh Kwan Kim

M.D., pHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Doh Kwan Kim, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Samsung Medical Center

Kangnam, Seoul, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2002-09-08

Identifier Type: -

Identifier Source: org_study_id