Predict Antidepressant Responsiveness Using Pharmacogenomics
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:
NCT01228357
First received: October 24, 2010
Last updated: June 29, 2012
Last verified: June 2012
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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:
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:
- 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:
|
|
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:
|
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
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:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental 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 Histamine H1 Antagonists Histamine Antagonists Histamine Agents |
ClinicalTrials.gov processed this record on May 22, 2013