Major Depressive DisorderAFADTRMDDNCT01454635
Analisis of Facors Involved in Antidepressant Treatment Response of Major Depressive Disorder
A study testing Sertraline in people with Major Depressive Disorder, run by Showa University at 1 site in Japan.
Trial summary
The purpose of this study is to predict and visualize sertraline treatment response in major depressive disorder with clinical symptoms, demographic and stress state, personality, eight genetic polymorphisms at baseline. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2008to Mar 2010
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of Major Depressive Disorder
- Must be able to swallow tablets
Who cannot join
- pregnant
- breastfeeding
Trial locations and contacts
1 site in 1 country.
Japan1 site
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503
About this study
Official title: Treatment Response Study of Sertraline to Treat Japanese Major Depressive Disorder
The purpose of this study is to predict and visualize sertraline treatment response in major depressive disorder with clinical symptoms, demographic and stress state, personality, eight genetic polymorphisms at baseline.
Read the detailed description
While only about 50% of patients respond to first treatment in major depressive disorder, 30-40% did not remit after continuous 1 year treatment. However, patients must remain on their prescribed medications for at least 4 weeks without knowing whether the particular antidepressant will be effective. Studies have suggested a number of predictors of treatment response, but varying degrees of success and nearly all with poor prognostic sensitivity and specificity. The investigators investigated clinical symptoms, demographic and stress state, personality and genetic polymorphisms in patients of major depressive disorder treated with sertraline and performed multivariate analysis to extract the predicting factors. Moreover, the investigators tried to visualize weight of variables and pathway one another.
- Conditions
- Major Depressive Disorder
- Being tested
- Sertraline
- Keywords
- depression, treatment response, selective serotonin reuptake inhibitor
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called J Zoloft®
dosage,frequency and duration
| Study group | Role | What they receive |
|---|---|---|
| Sertraline, Treatment response | Other | dosage, frequency and duration Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJun 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gentaro Nishioka, Showa University
- Investigators
- Yuji Kiuchi, Professor, Study director, Showa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454635
- Sponsor's protocol ID
- SU-GEC-84
- Acronym
- AFADTRMDD
- Status last verified
- Oct 2011
- First submitted
- 17 Oct 2011
- Last updated
- 31 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Response Study of Sertraline to Treat Japanese Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01454635
- Acronym / sponsor ID
- AFADTRMDD / SU-GEC-84
- Conditions
- Major Depressive Disorder
- Keywords
- depression, treatment response, selective serotonin reuptake inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Showa UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Oct 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 predict and visualize sertraline treatment response in major depressive disorder with clinical symptoms, demographic and stress state, personality, eight genetic polymorphisms at baseline.
Detailed description
While only about 50% of patients respond to first treatment in major depressive disorder, 30-40% did not remit after continuous 1 year treatment. However, patients must remain on their prescribed medications for at least 4 weeks without knowing whether the particular antidepressant will be effective. Studies have suggested a number of predictors of treatment response, but varying degrees of success and nearly all with poor prognostic sensitivity and specificity. The investigators investigated clinical symptoms, demographic and stress state, personality and genetic polymorphisms in patients of major depressive disorder treated with sertraline and performed multivariate analysis to extract the predicting factors. Moreover, the investigators tried to visualize weight of variables and pathway one another.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sertraline, Treatment response | Other | Drug: Sertralinedosage, frequency and duration |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of Major Depressive Disorder
- Must be able to swallow tablets
Key exclusion criteria (2 listed)
- pregnant
- breastfeeding
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 |
|---|---|---|
| SertralineAlso: J Zoloft®dosage,frequency and duration | Drug | Sertraline, Treatment response |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2011.
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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.
Yuji Kiuchi, Professor study director
Showa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertraline in people with Major Depressive Disorder, run by Showa University at 1 site in Japan.
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 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: finished, as of the sponsor's last update on 31 Oct 2011. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hamilton Rating Scale for Depression (time frame: 8 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 Oct 2011.