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Predict Antidepressant Responsiveness Using Pharmacogenomics

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ClinicalTrials.gov Identifier: NCT01228357
Recruitment Status : Recruiting
First Posted : October 26, 2010
Last Update Posted : December 31, 2015
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center

Brief Summary:
The purpose of this study is to determine whether genetic information associated with individual depressive symptoms.

Condition or disease Intervention/treatment
Depression Depressive Symptoms Drug: SSRI treated group Drug: non-SSRI treated group

Detailed Description:

The primary hypothesis is that the variations of the candidate genes are associated with individual symptoms in patients with depression.

The Second hypothesis is that patients with the associated genetic variation suffer longer from the associated symptom than the patients without the associated genetic variation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Predict Antidepressant Responsiveness Using Pharmacogenomics
Study Start Date : February 2003
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Arm Intervention/treatment
Experimental: SSRI treated group
SSRI treated group is patients treated with fluoxetine, paroxetine, or sertraline
Drug: SSRI treated group
Antidepressant administration of SSRI class for 12 weeks under therapeutic dose
Other Names:
  • fluoxetine_Prozac
  • paroxetine_Paxil, Seroxat
  • sertraline_Zoloft
Active Comparator: non-SSRI treated group
non-SSRI treated group is patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine
Drug: non-SSRI treated group
Antidepressant administration of non-SSRI class for 12 weeks under therapeutic dose
Other Names:
  • milnacipran
  • venlafaxine_Effexor
  • nortriptyline_Aventyl, Pamelor, Noritren
  • mirtazapine_Avanza, Zispin, Remeron

Primary Outcome Measures :
  1. Presences of each individual symptom of depression at 1,2,4,6,12 weeks [ Time Frame: 12 weeks ]
    17-items HAM-D scale was employed to measure depressive symptoms

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Ages Eligible for Study:   19 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228357

Contact: JungShil Back, B/Sc. 82-2-3410-0946 jungshil.back@sbri.co.kr
Contact: Shinn-Won Lim, phD 82-2-3410-3759 shinwon.lim@sbri.co.kr

Korea, Republic of
Samsung Medical Center Recruiting
Kangnam, Seoul, Korea, Republic of
Contact: Doh Kwan Kim, MD.PhD    82-2-3410-3582    dohkwan.kim@samsung.com   
Contact: Woojae Myung, MD.    82-2-3410-6562    smbhealer@gmail.com   
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Doh Kwan Kim, M.D., Ph.D. Samsung Medical Center

Responsible Party: Doh Kwan Kim, M.D., Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01228357     History of Changes
Other Study ID Numbers: 2003-08-07
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Doh Kwan Kim, Samsung Medical Center:
Depressed Patients

Additional relevant MeSH terms:
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Behavioral Symptoms
Venlafaxine Hydrochloride
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents