DepressionNCT01352572
Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients
A study testing antidepressant response and antidepressant non-response in people with Depression, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration, or represent the clinical status of depressed patients. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- antidepressant response and antidepressant non-response
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2002to Dec 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea.
- were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents
Who cannot join
- pregnancy
- significant medical conditions
- abnormal laboratory baseline values
- unstable psychiatric features (e.g, suicidal attempt)
- history of alcohol or drug dependence, seizure, neurological illness, or concomitant Axis I psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration, or represent the clinical status of depressed patients.
Read the detailed description
The purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.
- Conditions
- Depression
- Being tested
- antidepressant response, antidepressant non-response
- Keywords
- Antidepressant Response, Signal Transduction, Lymphocyte, Biomarkers, Depressed Patients, Antidepressant Drug Adverse Reaction
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antidepressant responseDrug
Also called fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, milnacipran
Antidepressants administration for 6 weeks under therapeutic dose responders
antidepressant non-responseDrug
Also called fluoxetine, paroxetine, sertraline, milnacipran, venlafaxine, nortriptyline, mirtazapine
Antidepressants administration for 6 weeks under therapeutic dose nonresponders
| Study group | Role | What they receive |
|---|---|---|
| antidepressant response | Experimental | antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score Receives: Drug: antidepressant response |
| antidepressant non-response | Active comparator | antidepressant non-response are refered the patients having a 50 > Decrease rate(%) of HAM-D score Receives: Drug: antidepressant non-response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antidepressant Response at 6 weeks
Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = or >50%
Measurement Unit = responders, nonresponders
Measured: 6 weeks
Secondary outcomes (1)
Biological value at 0 and 6 weeks
Biologial value is defined as protein expression value of signaling components in peripheral lymphocyte.
Measurement value : Optical Density(O.D), microgram/liter(ug/l)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startJan 2002
- Primary completionDec 2018 (estimated)
- Study completionDec 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 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, MD PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352572
- Sponsor's protocol ID
- 2002-09-08
- Status last verified
- Dec 2015
- First submitted
- 21 Apr 2011
- 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
- Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients
- ClinicalTrials.gov ID
- NCT01352572
- Acronym / sponsor ID
- 2002-09-08
- Conditions
- Depression
- Keywords
- Antidepressant Response, Signal Transduction, Lymphocyte, Biomarkers, Depressed Patients, Antidepressant Drug Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 May 2011 (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 determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration, or represent the clinical status of depressed patients.
Detailed description
The purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antidepressant response | Experimental | Drug: antidepressant responseantidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score |
| antidepressant non-response | Active comparator | Drug: antidepressant non-responseantidepressant non-response are refered the patients having a 50 > Decrease rate(%) of HAM-D score |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea.
- were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents
Key exclusion criteria (5 listed)
- pregnancy
- significant medical conditions
- abnormal laboratory baseline values
- unstable psychiatric features (e.g, suicidal attempt)
- history of alcohol or drug dependence, seizure, 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 |
|---|---|---|
| antidepressant responseAlso: fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, milnacipranAntidepressants administration for 6 weeks under therapeutic dose responders | Drug | antidepressant response |
| antidepressant non-responseAlso: fluoxetine, paroxetine, sertraline, milnacipran, venlafaxine, nortriptyline, mirtazapineAntidepressants administration for 6 weeks under therapeutic dose nonresponders | Drug | antidepressant non-response |
Primary outcome
Antidepressant Response at 6 weeks
Time frame: 6 weeks
Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = or >50% Measurement Unit = responders, nonresponders
1 secondary outcome
Biological value at 0 and 6 weeks
Time frame: 6 weeks
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, MD PhD 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 antidepressant response and antidepressant non-response in people with Depression, 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 2 inclusion and 5 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antidepressant Response at 6 weeks (time frame: 6 weeks). 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.