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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Drug: antidepressant response; Drug: antidepressant non-response

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Kangnam, Seoul, Korea, Republic of, 135-710
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: antidepressant response; antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score	Drug: antidepressant response; Antidepressants administration for 6 weeks under therapeutic dose responders; Other Names: milnacipran; fluoxetine_Prozac; paroxetine_Paxil, Seroxat; sertraline_Zoloft; venlafaxine_Effexor; nortriptyline_Aventyl, Pamelor, Noritren; mirtazapine_Avanza, Zispin, Remeron
Active Comparator: antidepressant non-response; antidepressant non-response are refered the patients having a 50 > Decrease rate(%) of HAM-D score	Drug: antidepressant non-response; Antidepressants administration for 6 weeks under therapeutic dose nonresponders; Other Names: fluoxetine, paroxetine, sertraline; milnacipran, venlafaxine, nortriptyline, mirtazapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological value at 0 and 6 weeks	Biologial value is defined as protein expression value of signaling components in peripheral lymphocyte. Measurement value : Optical Density(O.D), microgram/liter(ug/l)	6 weeks

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Doh Kwan Kim, MD PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: May 11, 2011
• First Posted (Estimate): May 12, 2011

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Biomarkers; Lymphocyte; Depressed Patients; Antidepressant Response; Signal Transduction; Antidepressant Drug Adverse Reaction
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Antidepressive Agents, Tricyclic; Cytochrome P-450 CYP2D6 Inhibitors; Serotonin 5-HT3 Receptor Antagonists; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic Uptake Inhibitors; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Sertraline; Paroxetine; Venlafaxine Hydrochloride; Mirtazapine; Nortriptyline; Fluoxetine; Milnacipran; Levomilnacipran; Antidepressive Agents
• Other Study ID Numbers: 2002-09-08