Major Depressive DisorderPhase 4NCT00353028
Fluvoxamine Maleate in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents
A Phase 4 study testing Fluvoxamine maleate in people with Major Depressive Disorder, run by Solvay Pharmaceuticals at 25 sites in Japan.
Trial summary
This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the treatment of children and adolescents with depression or depressive state Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Fluvoxamine maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 25 sitesJapan
- Study dates
- Oct 2006to Jul 2009
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria Have a minimum total score of 18 on the JSIGH-D, Weight is within the standard weight ± 2S.D. based on the standard weight for each age in the School Health Statistical Survey Exclusion Criteria Have the following predominant psychiatric diagnosis -Schizophrenia Have previously been treated with fluvoxamine maleate
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
S114.3.117 Kohnodai Hospital, National Center of N
Chiba Prefecture
S114.3.117 Fukuoka University Hospital
Fukuoka Prefecture
S114.3.117 Hatakeyama Clinic
Fukuoka Prefecture
S114.3.117 Kaname Clinic
Fukuoka Prefecture
S114.3.117 Kashi shinryo Clinic
Fukuoka Prefecture
S114.3.117 Kashii Sanatorium
Fukuoka Prefecture
S114.3.117 Kyushu University Hospital
Fukuoka Prefecture
S114.3.117 Shiranui Hospital
Fukuoka Prefecture
S114.3.117 Sugahara Tenjin Hospital
Fukuoka Prefecture
S114.3.117 Hiroshima-city Funairi Hospital
Hiroshima Prefecture
S114.3.117 Goryokai Hospital
Hokkaido Prefecture
S114.3.117 Kobe University Hospital
Hyogo Prefecture
S114.3.117 National Hospital Organization Kagawa C
Kagawa Prefecture
S114.3.117 Yokohama City University Hospital
Kanagawa Prefecture
S114.3.117 National Hospital Organization Kikuti N
Kumamoto Prefecture
S114.3.117 Kyoto University Hospital
Kyoto Prefecture
S114.3.117 National Hospital Organization Sakakiba
Mie Prefecuture
S114.3.117 Shinshu University Hospital
Nagano Prefecture
S114.3.117 Aichi Children's Health and Medical Cen
Nagoya Prefecture
S114.3.117 Nagoya Mental Clinic
Nagoya Prefecture
S114.3.117 Nara Medical University Hospital
Nara Prefecture
S114.3.117 Kansai Medical University Takii Hospita
Osaka Prefecture
S114.3.117 Kusube Clinic
Osaka Prefecture
S114.3.117 Yasuhara Children's Clinic
Osaka Prefecture
S114.3.117 Tokushima University Hospital
Tokushima Prefecture
About this study
Official title: SME3110 (Fluvoxamine Maleate) in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents (8 Through 18 Years of Age) -A Double-blind, Randomized, Placeb-controlled Study
This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the treatment of children and adolescents with depression or depressive state
- Conditions
- Major Depressive Disorder
- Being tested
- Fluvoxamine maleate, Placebo
- Keywords
- Fluvoxamine Maleate, Depression, Children and Adolescents
- 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.
Fluvoxamine maleateDrug
Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| F | Experimental | Not described Receives: Drug: Fluvoxamine maleate |
| P | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time of onset of 50% decrease from baseline in the Japanese Version of the Structured Interview Guide for the Hamilton Depression Rating Scale (JSIGH-D) 17-item total score
Measured: 8 weeks
Secondary outcomes (1)
The Clinical Global Impression(CGI) improvement at Week 8
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 posted17 Jul 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2009
- Study completionJul 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Toshiaki Yamaguchi, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353028
- Sponsor's protocol ID
- S114.3.117
- Status last verified
- Mar 2010
- First submitted
- 14 Jul 2006
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SME3110 (Fluvoxamine Maleate) in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents (8 Through 18 Years of Age) -A Double-blind, Randomized, Placeb-controlled Study
- ClinicalTrials.gov ID
- NCT00353028
- Acronym / sponsor ID
- S114.3.117
- Conditions
- Major Depressive Disorder
- Keywords
- Fluvoxamine Maleate, Depression, Children and Adolescents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 17 Jul 2006 (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.
This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the treatment of children and adolescents with depression or depressive state
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F | Experimental | Drug: Fluvoxamine maleate |
| P | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Fluvoxamine maleateTest product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica | Drug | F |
| PlaceboPlacebo | Drug | P |
Primary outcome
the time of onset of 50% decrease from baseline in the Japanese Version of the Structured Interview Guide for the Hamilton Depression Rating Scale (JSIGH-D) 17-item total score
Time frame: 8 weeks
1 secondary outcome
The Clinical Global Impression(CGI) improvement at Week 8
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 4 Mar 2010.
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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 Yamaguchi study director
Solvay Pharmaceuticals
25 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 Fluvoxamine maleate in people with Major Depressive Disorder, run by Solvay Pharmaceuticals at 25 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?
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 4 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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. Some participants in this study may receive a placebo. 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?
the time of onset of 50% decrease from baseline in the Japanese Version of the Structured Interview Guide for the Hamilton Depression Rating Scale (JSIGH-D) 17-item total score (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 4 Mar 2010.