Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)
This study is currently recruiting participants.
Verified June 2012 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00817011
First received: January 5, 2009
Last updated: June 29, 2012
Last verified: June 2012
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Purpose
The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.
| Condition | Intervention |
|---|---|
|
Depression Antidepressant Drug Adverse Reaction |
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: | Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness |
Resource links provided by NLM:
Drug Information available for:
Nortriptyline
Nortriptyline hydrochloride
Trazodone
Trazodone hydrochloride
Bupropion hydrochloride
Bupropion
Fluoxetine
Fluoxetine hydrochloride
Citalopram hydrobromide
Citalopram
Paroxetine
Paroxetine hydrochloride
Sertraline hydrochloride
Sertraline
Mirtazapine
Venlafaxine
Venlafaxine hydrochloride
Paroxetine hydrochloride hemihydrate
Duloxetine
Duloxetine hydrochloride
Paroxetine Mesylate
Escitalopram oxalate
U.S. FDA Resources
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- all pharmacogenetic and biological marker variables cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- all clinical cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | March 2015 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SSRI treated group
SSRI treated with fluoxetine, paroxetine, citalopram or sertraline
|
Drug: SSRI class antidepressant
Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
Other Names:
|
|
Active Comparator: non-SSRI treated group
non-SSRI treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine
|
Drug: non-SSRI class antidepressant
Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose
Other Names:
|
Detailed Description:
The difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) The time lag is existed until the patients respond to antidepressant and show the treatment effects.
If it is predicted the response of antidepressant in advance, it would be overcome such problems. Drug response generally is known to be related to the individual genetic information and the environmental factors. We are going to investigation about antidepressant response using these approaches.
Eligibility| Ages Eligible for Study: | 25 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 25 < age <85
- major depressed patients satisfied with the diagnosis criteria depression of DSM-IV
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817011
Contacts
| Contact: Doh Kwan Kim, M.D.,Ph.D | 82-2-3410-0946 | jungshil.back@sbri.co.kr |
| 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, 135-710 | |
| Contact: DohKwan Kim | |
| Principal Investigator: Doh Kwan Kim, ph.D, M.D. | |
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: | NCT00817011 History of Changes |
| Other Study ID Numbers: | 2006-03-012 |
| Study First Received: | January 5, 2009 |
| Last Updated: | June 29, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Samsung Medical Center:
|
depression pharmacogenomics antidepressant response biological markers clinical variables |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Drug Toxicity Behavioral Symptoms Mood Disorders Mental Disorders Poisoning Substance-Related Disorders Trazodone Citalopram Fluoxetine Paroxetine Sertraline Venlafaxine Duloxetine |
Bupropion Antidepressive Agents Nortriptyline Mirtazapine Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
ClinicalTrials.gov processed this record on June 17, 2013