Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype

Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype

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.

Study Overview

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

Detailed Description

The purpose of this study is to determine whether genomic effects or peripheral lymphatic biomarkers on antidepressant response differed by class of drug, whether genomic and biomarker differences between drug responders and nonresponders predict the response of antidepressant and to construct the prediction model for antidepressant treatment in order to aid to select the their genetically or endophenotypic matching drugs.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• 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: 19 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
2. 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.

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: responders; 50 ≤ Decrease rate(%) of HAM-D score	Drug: responders; Antidepressants administration for 6 weeks under therapeutic dose; Other Names: milnacipran; fluoxetine_Prozac; paroxetine_Paxil, Seroxat; sertraline_Zoloft; venlafaxine_Effexor; nortriptyline_Aventyl, Pamelor, Noritren; mirtazapine_Avanza, Zispin, Remeron
Active Comparator: non-responders; nonresponders is a patients having 50 > Decrease rate(%) of HAM-D score	Drug: non-responders; Antidepressants administration for 6 weeks under therapeutic dose; Other Names: SSRI nonresponders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological value at 0 and 6 weeks	Biological value is defined as; Genetic information of bioamine transporter genes of patients. Measurement unit = if it is SNP,it is A, T, G, or C, and if VNTR, short or long alleleor; Biological measure value of patients at 0 and 6week after antidepressant treatment(ex. peripheral markers such as serum BDNF, CREB...). Measurement unit = numerical value and thier unit such as O.D.(Optical Density)	6 weeks

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Doh Kwan Kim, M.D., Ph.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): March 1, 2007
• 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; Pharmacogenomics; phenotype; Depressed Patients; Adverse Reaction to Drug; Prediction of Antidepressant Response; Antidepressant Response
• 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; Antidepressive 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
• Other Study ID Numbers: 2001-11-03