DepressionPGNCT00817011
Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness
A study testing SSRI treated group and non-SSRI treated group in people with Depression and Antidepressant Drug Adverse Reaction, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients. Read more about this study
- Who is it for?
- Ages 25 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Antidepressant Drug Adverse Reaction
- What is being tested?
- SSRI treated group and non-SSRI treated group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2006to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Kangnam, Seoul, 135-710
DohKwan Kim
Doh Kwan Kim, ph.D, M.D.
About this study
Official title: Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness
The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.
Read the 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.
- Conditions
- Depression, Antidepressant Drug Adverse Reaction
- Being tested
- SSRI treated group, non-SSRI treated group
- Keywords
- depression, pharmacogenomics, antidepressant response, biological markers, clinical variables
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSRI treated groupDrug
Also called Other Names:, fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft
Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
non-SSRI treated groupDrug
Also called venlafaxine_Effexor, nortriptyline_Aventyl, Pamelor, Noritren, mirtazapine_Avanza, Zispin, Remeron, bupropion_amfebutamone, Wellbutrin, Zyban
Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose
| Study group | Role | What they receive |
|---|---|---|
| SSRI treated group | Experimental | SSRI treated group are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline Receives: Drug: SSRI treated group |
| non-SSRI treated group | Active comparator | non-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine Receives: Drug: non-SSRI treated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
all pharmacogenetic and biological marker variables cause drug response
Measured: 24weeks
Secondary outcomes (1)
all clinical cause drug response
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startApr 2006
- Primary completionDec 2016 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doh Kwan Kim, Samsung Medical Center
- Investigators
- Doh Kwan Kim, M.D.,Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817011
- Sponsor's protocol ID
- 2006-03-012
- Acronym
- PG
- Status last verified
- Dec 2015
- First submitted
- 5 Jan 2009
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness
- ClinicalTrials.gov ID
- NCT00817011
- Acronym / sponsor ID
- PG / 2006-03-012
- Conditions
- Depression, Antidepressant Drug Adverse Reaction
- Keywords
- depression, pharmacogenomics, antidepressant response, biological markers, clinical variables
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSRI treated group | Experimental | Drug: SSRI treated groupSSRI treated group are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline |
| non-SSRI treated group | Active comparator | Drug: non-SSRI treated groupnon-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSRI treated groupAlso: Other Names:, fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_ZoloftAntidepressant administration of SSRI class for 6 weeks under therapeutic dose | Drug | SSRI treated group |
| non-SSRI treated groupAlso: venlafaxine_Effexor, nortriptyline_Aventyl, Pamelor, Noritren, mirtazapine_Avanza, Zispin, Remeron, bupropion_amfebutamone, Wellbutrin, ZybanAntidepressant administration of non-SSRI class for 6 weeks under therapeutic dose | Drug | non-SSRI treated group |
Primary outcome
all pharmacogenetic and biological marker variables cause drug response
Time frame: 24weeks
1 secondary outcome
all clinical cause drug response
Time frame: 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doh Kwan Kim, M.D.,Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSRI treated group and non-SSRI treated group in people with Depression and Antidepressant Drug Adverse Reaction, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doh Kwan Kim, M.D.,Ph.D (82-2-3410-0946, jungshil.back@sbri.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all pharmacogenetic and biological marker variables cause drug response (time frame: 24weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2015.