DepressionNCT03403790
A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
An observational study of Depression and Bipolar Disorder, run by Astellas Pharma Inc at 47 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression, Bipolar Disorder
- What is being tested?
- Quetiapine
- Type of treatment
- Pill or oral medicine
- How many people
- 369 participants
- Where
- 47 sitesJapan
- Study dates
- 15 Jan 2018to 19 Mar 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with depressive symptoms of bipolar disorder who have not been treated with quetiapine fumarate
Who may be able to join
- Patients with depressive symptoms of bipolar disorder
- Patients who have previously not been treated with quetiapine fumarate (immediate-release formulations of quetiapine fumarate and Bipresso Extended-Release Tablets)
Who cannot join
- None
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Site JP00023
Aichi
Site JP00005
Akita
Site JP00002
Aomori
Site JP00012
Chiba
Site JP00038
Ehime
Site JP00018
Fukui
Site JP00040
Fukuoka
Site JP00007
Fukushima
Site JP00021
Gifu
Site JP00010
Gunma
Site JP00034
Hiroshima
Site JP00001
Hokkaido
Site JP00028
Hyōgo
Site JP00008
Ibaraki
Site JP00017
Ishikawa
Site JP00037
Kagawa
Site JP00046
Kagoshima
Site JP00014
Kanagawa
Site JP00039
Kochi
Site JP00043
Kumamoto
Site JP00026
Kyoto
Site JP00024
Mie
Site JP00004
Miyagi
Site JP00045
Miyazaki
Site JP00020
Nagano
Site JP00042
Nagasaki
Site JP00029
Nara
Site JP00015
Niigata
Site JP00003
Numakunai
Site JP00044
Ōita
Site JP00033
Okayama
Site JP00047
Okinawa
Site JP00027
Osaka
Site JP00041
Saga
Site JP00011
Saitama
Site JP00025
Shiga
Site JP00032
Shimane
Site JP00022
Shizuoka
Site JP00009
Tochigi
Site JP00036
Tokushima
Site JP00013
Tokyo
Site JP00031
Tottori
Site JP00016
Toyama
Site JP00030
Wakayama
Site JP00006
Yamagata
Site JP00035
Yamaguchi
Site JP00019
Yamanashi
About this study
Official title: Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.
Read the detailed description
This is a post-marketing use-result survey study required for products in Japan. The investigator will register the patient who have been taking this product for the first time within 14 days after the start of treatment (inclusive of the start day). For each of the registered patients (including withdrawals and dropouts), the investigator will enter the survey data on the case report form.
- Conditions
- Depression, Bipolar Disorder
- Being tested
- Quetiapine
- Keywords
- Bipresso, Drug use-results survey, Quetiapine
- Medical subject headings
- Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Also called Bipresso
Oral (extended-release tablet)
| Study group | Role | What they receive |
|---|---|---|
| Patients with depression in bipolar disorder | Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by incidence of serious adverse events
To assess incidence of serious adverse events as a criteria of safety variables.
Measured: Up to Week 12
Safety assessed by incidence of adverse drug reactions
To assess incidence of adverse drug reactions as a criteria of safety variables.
Measured: Up to Week 12
Safety assessed by laboratory values and changes from baseline over time
To assess profile of laboratory value transition and potential clinical significance as a criteria of safety variables. The investigators will assess the severity and clinical relevance, and will report as an adverse event as necessary.
Measured: Up to Week 12
Safety assessed by vital signs: Blood pressure (sitting)
To assess blood pressure as a criteria of safety variables
Measured: Up to Week 12
Safety assessed by vital signs: Pulse rate (sitting)
To assess pulse rate as a criteria of safety variables
Measured: Up to Week 12
Safety assessed by 12-lead electrocardiogram
To assess 12-lead electrocardiogram as a criteria of safety variables
Measured: Up to Week 12
Safety assessed by body weight
To assess body weight as a criteria of safety variables
Measured: Up to Week 12
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
To assess MADRS as a criteria of efficacy variables
Measured: Baseline and up to Week 12
Change from baseline in Clinical Global Impression-Bipolar-Severity of illness (CGI-BP-S)
To assess CGI-BP-S as a criteria of efficacy variables
Measured: Baseline and up to Week 12
Efficacy assessed by Clinical Global Impression-Bipolar-Change (CGI-BP-C)
To assess CGI-BP-C as a criteria of efficacy variables
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start15 Jan 2018
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403790
- Sponsor's protocol ID
- 6949-MA-3199
- Status last verified
- Apr 2020
- First submitted
- 7 Jan 2018
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03403790
- Acronym / sponsor ID
- 6949-MA-3199
- Conditions
- Depression, Bipolar Disorder
- Keywords
- Bipresso, Drug use-results survey, Quetiapine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 19 Jan 2018 (actual)
- 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 evaluate the safety and effectiveness of quetiapine in actual clinical settings.
Detailed description
This is a post-marketing use-result survey study required for products in Japan. The investigator will register the patient who have been taking this product for the first time within 14 days after the start of treatment (inclusive of the start day). For each of the registered patients (including withdrawals and dropouts), the investigator will enter the survey data on the case report form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with depression in bipolar disorder | – | Drug: QuetiapinePatients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with depressive symptoms of bipolar disorder who have not been treated with quetiapine fumarate
Key inclusion criteria (2 listed)
- Patients with depressive symptoms of bipolar disorder
- Patients who have previously not been treated with quetiapine fumarate (immediate-release formulations of quetiapine fumarate and Bipresso Extended-Release Tablets)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| QuetiapineAlso: BipressoOral (extended-release tablet) | Drug | Patients with depression in bipolar disorder |
Primary outcome
Safety assessed by incidence of serious adverse events
Time frame: Up to Week 12
To assess incidence of serious adverse events as a criteria of safety variables.
Safety assessed by incidence of adverse drug reactions
Time frame: Up to Week 12
To assess incidence of adverse drug reactions as a criteria of safety variables.
Safety assessed by laboratory values and changes from baseline over time
Time frame: Up to Week 12
To assess profile of laboratory value transition and potential clinical significance as a criteria of safety variables. The investigators will assess the severity and clinical relevance, and will report as an adverse event as necessary.
Safety assessed by vital signs: Blood pressure (sitting)
Time frame: Up to Week 12
To assess blood pressure as a criteria of safety variables
Safety assessed by vital signs: Pulse rate (sitting)
Time frame: Up to Week 12
To assess pulse rate as a criteria of safety variables
Safety assessed by 12-lead electrocardiogram
Time frame: Up to Week 12
To assess 12-lead electrocardiogram as a criteria of safety variables
Safety assessed by body weight
Time frame: Up to Week 12
To assess body weight as a criteria of safety variables
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline and up to Week 12
To assess MADRS as a criteria of efficacy variables
Change from baseline in Clinical Global Impression-Bipolar-Severity of illness (CGI-BP-S)
Time frame: Baseline and up to Week 12
To assess CGI-BP-S as a criteria of efficacy variables
Efficacy assessed by Clinical Global Impression-Bipolar-Change (CGI-BP-C)
Time frame: Up to Week 12
To assess CGI-BP-C as a criteria of efficacy variables
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 16 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Central Contact study director
Astellas Pharma Inc
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Bipolar Disorder, run by Astellas Pharma Inc at 47 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 2 inclusion and 1 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 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.
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?
Safety assessed by incidence of serious adverse events (time frame: Up to Week 12). The study lists 10 primary outcomes in all. 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 16 Oct 2024.