Predict Antidepressant Responsiveness Using Pharmacogenomics

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01228357
First received: October 24, 2010
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Depression
Depressive Symptoms
Drug: SSRI class antidepressant
Drug: non-SSRI class antidepressant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Predict Antidepressant Responsiveness Using Pharmacogenomics

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

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


Estimated Enrollment: 1000
Study Start Date: February 2003
Estimated Study Completion Date: March 2015
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SSRI treated group
SSRI treated with fluoxetine, paroxetine, or sertraline
Drug: SSRI class antidepressant
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 with milnacipran, venlafaxine, nortriptyline, or mirtazapine
Drug: non-SSRI class antidepressant
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228357

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

Locations
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
Investigators
Principal Investigator: Doh Kwan Kim, M.D., Ph.D. Samsung Medical Center
  More Information

No publications provided

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
Study First Received: October 24, 2010
Last Updated: June 29, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Pharmacogenomics
Depressed Patients

Additional relevant MeSH terms:
Antidepressive Agents
Antidepressive Agents, Tricyclic
Depression
Behavioral Symptoms
Nortriptyline
Adrenergic Agents
Adrenergic Uptake Inhibitors
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014