Unipolar Major Depressive EpisodePhase 4SUN(^_^)DNCT01109693
Strategic Use of New Generation Antidepressants for Depression
A Phase 4 study testing Sertraline and Mirtazapine in people with Unipolar Major Depressive Episode, run by Kyoto University at 2 sites in Japan.
Trial summary
The purpose of the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Unipolar Major Depressive Episode
- What is being tested?
- Sertraline and Mirtazapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,011 participants
- Where
- 2 sitesJapan
- Study dates
- Dec 2010to Dec 2015
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-psychotic unipolar major depressive episode (Diagnostic and Statistical Manual, Fourth Edition [DSM-IV]) in the preceding month
- age 25-75
- starting treatment with sertraline clinically indicated
- tolerability to sertraline 25 mg/d ascertained
- can understand and sign informed consent form
- can be contacted by telephone for symptom severity and adverse events
Who cannot join
- have received antidepressants, mood stabilizers, antipsychotics, psychostimulants, electroconvulsive therapy (ECT) or depression-specific psychotherapies in the preceding month
- history of schizophrenia, schizoaffective disorder or bipolar disorder
- current dementia, borderline personality disorder, eating disorder or substance dependence
- physical disease interfering with sertraline or mirtazapine treatment
- allergy to sertraline or mirtazapine
- terminal physical illness
Show all 12Show fewer
- currently pregnant or breast-feeding
- high risk of imminent suicide
- requiring compulsory admission
- expected to change doctors within 6 months
- cohabiting relatives of research staff
- cannot understand Japanese
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Kochi Medical School Hospital
Nangoku, Kochi, 783-8505
About this study
The purpose of the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression.
- Conditions
- Unipolar Major Depressive Episode
- Being tested
- Sertraline, Mirtazapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Sertraline 50 mg/d or 100 mg/d for 6 more weeks
MirtazapineDrug
Augment with or switch to mirtazapine 15-45 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Continue sertraline | Active comparator | Continue sertraline at the dosage at 3 weeks Receives: Drug: Sertraline |
| Augment with mirtazapine | Active comparator | Add mirtazapine to sertraline Receives: Drug: Sertraline; Drug: Mirtazapine |
| Switch to mirtazapine | Active comparator | Stop sertraline and switch to mirtazapine Receives: Drug: Mirtazapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observer-rated depression severity (PHQ-9)
Personal Health Questionnaire-9 is a 9-item structured interview to measure depression severity. It will be rated by blinded telephone interview.
Measured: 9 weeks
Secondary outcomes (2)
Self-rated depression severity (BDI-II)
Beck Depression Inventory-II is a 21-item self-report of depression severity. It will be filled in by the patients themselves.
Measured: 9 weeks
Global rating of side effects (FIBSER)
FIBSER stands for Frequency, Intensity and Burden of Side Effects Rating, which is an observer-rated global rating of side effects.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Unipolar Major Depressive EpisodeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Neurology and Psychiatry, Japan
- Responsible party
- Principal investigator, Toshiaki A. Furukawa, Kyoto University
- Investigators
- Toshiaki A Furukawa, MD, PhD, Principal investigator, Kyoto University Graduate School of Medicine / School of Public HealthTatsuo Akechi, MD, PhD, Study director, Nagoya City University Graduate School of Medical SciencesNorio Watanabe, MD, PhD, Study director, National Center of Neurology and Psychiatry, JapanShinji Shimodera, MD, PhD, Study director, Kochi University Medical SchoolMitsuhiko Yamada, MD, PhD, Study director, National Center of Neurology and Psychiatry, JapanMasatoshi Inagaki, MD, PhD, Study director, Okayama University Graudate School of MedicineNaohiro Yonemoto, MSc, Study director, National Center of Neurology and Psychiatry, JapanKazuhira Miki, MD, PhD, Study director, Miki Mental Clinic, Yokohama, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109693
- Sponsor's protocol ID
- sun-d
- Acronym
- SUN(^_^)D
- Status last verified
- Sep 2016
- First submitted
- 21 Apr 2010
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kato T, Furukawa TA, Mantani A, Kurata K, Kubouchi H, Hirota S, Sato H, Sugishita K, Chino B, Itoh K, Ikeda Y, Shinagawa Y, Kondo M, Okamoto Y, Fujita H, Suga M, Yasumoto S, Tsujino N, Inoue T, Fujise N, Akechi T, Yamada M, Shimodera S, Watanabe N, Inagaki M, Miki K, Ogawa Y, Takeshima N, Hayasaka Y, Tajika A, Shinohara K, Yonemoto N, Tanaka S, Zhou Q, Guyatt GH; SUN☺D Investigators. Optimising first- and second-line treatment strategies for untreated major depressive disorder - the SUN☺D study: a pragmatic, multi-centre, assessor-blinded randomised controlled trial. BMC Med. 2018 Jul 11;16(1):103. doi: 10.1186/s12916-018-1096-5.
PubMed 29991347Yonemoto N, Tanaka S, Furukawa TA, Kato T, Mantani A, Ogawa Y, Tajika A, Takeshima N, Hayasaka Y, Shinohara K, Miki K, Inagaki M, Shimodera S, Akechi T, Yamada M, Watanabe N, Guyatt GH; SUN(;_;)D Investigators. Strategic use of new generation antidepressants for depression: SUN(;_;) D protocol update and statistical analysis plan. Trials. 2015 Oct 14;16:459. doi: 10.1186/s13063-015-0985-6.
PubMed 26466684Shimodera S, Kato T, Sato H, Miki K, Shinagawa Y, Kondo M, Fujita H, Morokuma I, Ikeda Y, Akechi T, Watanabe N, Yamada M, Inagaki M, Yonemoto N, Furukawa TA; SUN(;_;)D Investigators. The first 100 patients in the SUN(;_;)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase. Trials. 2012 Jun 8;13:80. doi: 10.1186/1745-6215-13-80.
PubMed 22682213Furukawa TA, Akechi T, Shimodera S, Yamada M, Miki K, Watanabe N, Inagaki M, Yonemoto N. Strategic use of new generation antidepressants for depression: SUN(;_;)D study protocol. Trials. 2011 May 11;12:116. doi: 10.1186/1745-6215-12-116.
PubMed 21569309
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Use of New Generation Antidepressants for Depression
- ClinicalTrials.gov ID
- NCT01109693
- Acronym / sponsor ID
- SUN(^_^)D / sun-d
- Conditions
- Unipolar Major Depressive Episode
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,011 participants (actual)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Collaborators
- National Center of Neurology and Psychiatry, Japan
- Study start
- Dec 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Apr 2010 (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 the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continue sertraline | Active comparator | Drug: SertralineContinue sertraline at the dosage at 3 weeks |
| Augment with mirtazapine | Active comparator | Drug: Sertraline, Drug: MirtazapineAdd mirtazapine to sertraline |
| Switch to mirtazapine | Active comparator | Drug: MirtazapineStop sertraline and switch to mirtazapine |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- non-psychotic unipolar major depressive episode (Diagnostic and Statistical Manual, Fourth Edition [DSM-IV]) in the preceding month
- age 25-75
- starting treatment with sertraline clinically indicated
- tolerability to sertraline 25 mg/d ascertained
- can understand and sign informed consent form
Key exclusion criteria (12 listed)
- have received antidepressants, mood stabilizers, antipsychotics, psychostimulants, electroconvulsive therapy (ECT) or depression-specific psychotherapies in the preceding month
- history of schizophrenia, schizoaffective disorder or bipolar disorder
- current dementia, borderline personality disorder, eating disorder or substance dependence
- physical disease interfering with sertraline or mirtazapine treatment
- allergy to sertraline or mirtazapine
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 |
|---|---|---|
| SertralineSertraline 50 mg/d or 100 mg/d for 6 more weeks | Drug | Augment with mirtazapine, Continue sertraline |
| MirtazapineAugment with or switch to mirtazapine 15-45 mg/d | Drug | Augment with mirtazapine, Switch to mirtazapine |
Primary outcome
Observer-rated depression severity (PHQ-9)
Time frame: 9 weeks
Personal Health Questionnaire-9 is a 9-item structured interview to measure depression severity. It will be rated by blinded telephone interview.
2 secondary outcomes
Self-rated depression severity (BDI-II)
Time frame: 9 weeks
Global rating of side effects (FIBSER)
Time frame: 9 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 3 Oct 2016.
- Derived from this study: PubMed 29991347Kato T, Furukawa TA, Mantani A, Kurata K, Kubouchi H, Hirota S, Sato H, Sugishita K, Chino B, Itoh K, Ikeda Y, Shinagawa Y, Kondo M, Okamoto Y, Fujita H, Suga M, Yasumoto S, Tsujino N, Inoue T, Fujise N, Akechi T, Yamada M, Shimodera S, Watanabe N, Inagaki M, Miki K, Ogawa Y, Takeshima N, Hayasaka Y, Tajika A, Shinohara K, Yonemoto N, Tanaka S, Zhou Q, Guyatt GH; SUN☺D Investigators. Optimising first- and second-line treatment strategies for untreated major depressive disorder - the SUN☺D study: a pragmatic, multi-centre, assessor-blinded randomised controlled trial. BMC Med. 2018 Jul 11;16(1):103. doi: 10.1186/s12916-018-1096-5.
- Derived from this study: PubMed 26466684Yonemoto N, Tanaka S, Furukawa TA, Kato T, Mantani A, Ogawa Y, Tajika A, Takeshima N, Hayasaka Y, Shinohara K, Miki K, Inagaki M, Shimodera S, Akechi T, Yamada M, Watanabe N, Guyatt GH; SUN(;_;)D Investigators. Strategic use of new generation antidepressants for depression: SUN(;_;) D protocol update and statistical analysis plan. Trials. 2015 Oct 14;16:459. doi: 10.1186/s13063-015-0985-6.
- Derived from this study: PubMed 22682213Shimodera S, Kato T, Sato H, Miki K, Shinagawa Y, Kondo M, Fujita H, Morokuma I, Ikeda Y, Akechi T, Watanabe N, Yamada M, Inagaki M, Yonemoto N, Furukawa TA; SUN(;_;)D Investigators. The first 100 patients in the SUN(;_;)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase. Trials. 2012 Jun 8;13:80. doi: 10.1186/1745-6215-13-80.
- Derived from this study: PubMed 21569309Furukawa TA, Akechi T, Shimodera S, Yamada M, Miki K, Watanabe N, Inagaki M, Yonemoto N. Strategic use of new generation antidepressants for depression: SUN(;_;)D study protocol. Trials. 2011 May 11;12:116. doi: 10.1186/1745-6215-12-116.
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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.
Toshiaki A Furukawa, MD, PhD principal investigator
Kyoto University Graduate School of Medicine / School of Public Health
Tatsuo Akechi, MD, PhD study director
Nagoya City University Graduate School of Medical Sciences
Norio Watanabe, MD, PhD study director
National Center of Neurology and Psychiatry, Japan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sertraline and Mirtazapine in people with Unipolar Major Depressive Episode, run by Kyoto University at 2 sites 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 6 inclusion and 12 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 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Observer-rated depression severity (PHQ-9) (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01109693, which also lists 4 linked publications.
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 3 Oct 2016.