Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients
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:
NCT00817375
First received: January 5, 2009
Last updated: June 29, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.
| Condition | Intervention |
|---|---|
|
Depression Adverse Reaction to Drug |
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: | Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients |
Resource links provided by NLM:
Drug Information available for:
Nortriptyline
Nortriptyline hydrochloride
Fluoxetine
Fluoxetine hydrochloride
Paroxetine
Paroxetine hydrochloride
Sertraline hydrochloride
Sertraline
Mirtazapine
Milnacipran
Venlafaxine
Venlafaxine hydrochloride
Milnacipran hydrochloride
Paroxetine hydrochloride hemihydrate
Paroxetine Mesylate
U.S. FDA Resources
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Biological value at 0 and 6 weeks [ Time Frame: 6weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | March 2015 |
| Primary Completion Date: | December 2008 (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 6 weeks under therapeutic dose
Other Names:
|
|
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 6 weeks under therapeutic dose
Other Names:
|
Detailed Description:
The purpose of this study is
- to determine whether genomic effects on antidepressant response differed by class of drug,
- whether genomic 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 matching drugs.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817375
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@samsung.com |
Locations
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Kangnam, Seoul, Korea, Republic of, 135-710 | |
| Contact: Samsung Medical Center Kim, MD.pHD 82-2-3410-3582 dohkwan.kim@samsung.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., pHD, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT00817375 History of Changes |
| Other Study ID Numbers: | 2003-01-12 |
| Study First Received: | January 5, 2009 |
| Last Updated: | June 29, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Samsung Medical Center:
|
Pharmacogenomics Prediction of Antidepressant Response Depressed Patients |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Drug Toxicity Behavioral Symptoms Mood Disorders Mental Disorders Poisoning Substance-Related Disorders Antidepressive Agents Fluoxetine Nortriptyline Mirtazapine Milnacipran Paroxetine Sertraline |
Venlafaxine Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Adrenergic Uptake Inhibitors Adrenergic Agents Antidepressive Agents, Tricyclic |
ClinicalTrials.gov processed this record on May 19, 2013