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CompletedNCT01725308

FK949E: Placebo-controlled, Double-blind, Parallel-group Comparative Study and Open-label, Non-controlled Extension Study for depression

This study is completed in Japan. It is testing FK949E: Placebo-controlled, Double-blind, Parallel-group Comparative Study and Open-label, Non-controlled Extension Study for depression.

Bipolarity, DepressionDrugFrom 20 Years to 64 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

Then choose your country and confirm availability with each study site.

In plain English

Key information made simple

What is this study testing?

This study is testing whether FK949E may be useful for adults experiencing bipolarity.

What would participation involve?

Participants may receive FK949E, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Japan.

Who is it mainly for?

This study appears to be mainly for adults with bipolarity.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: February 7, 2012
Recruitment status
Completed
Enrollment listed in the registry
431
Sponsor
Astellas Pharma Inc
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2, Phase 3This study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.
Locations
Japan
Age range
From 20 Years to 64 Years
Official registry ID
NCT01725308
Official title
Phase II/III Study of FK949E: Placebo-controlled, Double-blind, Parallel-group Comparative Study and Open-label, Non-controlled Extension Study in Bipolar Disorder Patients With Major Depressive Episodes

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Japan · 98 sites
  • Site JP00030
    Aichi
    Site status: Not listed — confirm with the team
  • Site JP00031
    Aichi
    Site status: Not listed — confirm with the team
  • Site JP00052
    Aichi
    Site status: Not listed — confirm with the team
  • Site JP00055
    Aichi
    Site status: Not listed — confirm with the team
  • Site JP00072
    Aichi
    Site status: Not listed — confirm with the team
  • Site JP00092
    Aichi
    Site status: Not listed — confirm with the team
  • Site JP00003
    Akita
    Site status: Not listed — confirm with the team
  • Site JP00008
    Chiba
    Site status: Not listed — confirm with the team
  • Site JP00009
    Chiba
    Site status: Not listed — confirm with the team
  • Site JP00002
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00037
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00038
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00039
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00040
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00041
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00058
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00082
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00083
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00091
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00094
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00095
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00096
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00097
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00098
    Fukuoka
    Site status: Not listed — confirm with the team
  • Site JP00004
    Fukushima
    Site status: Not listed — confirm with the team
  • Site JP00028
    Gifu
    Site status: Not listed — confirm with the team
  • Site JP00006
    Gunma
    Site status: Not listed — confirm with the team
  • Site JP00007
    Gunma
    Site status: Not listed — confirm with the team
  • Site JP00035
    Hiroshima
    Site status: Not listed — confirm with the team
  • Site JP00056
    Hiroshima
    Site status: Not listed — confirm with the team
  • Site JP00067
    Hiroshima
    Site status: Not listed — confirm with the team
  • Site JP00001
    Hokkaido
    Site status: Not listed — confirm with the team
  • Site JP00059
    Hokkaido
    Site status: Not listed — confirm with the team
  • Site JP00061
    Hokkaido
    Site status: Not listed — confirm with the team
  • Site JP00062
    Hokkaido
    Site status: Not listed — confirm with the team
  • Site JP00068
    Hokkaido
    Site status: Not listed — confirm with the team
  • Site JP00069
    Hokkaido
    Site status: Not listed — confirm with the team
  • Site JP00073
    Hokkaido
    Site status: Not listed — confirm with the team
  • Site JP00074
    Hokkaido
    Site status: Not listed — confirm with the team
  • Site JP00076
    Hokkaido
    Site status: Not listed — confirm with the team
  • Site JP00005
    Ibaraki
    Site status: Not listed — confirm with the team
  • Site JP00049
    Kagawa
    Site status: Not listed — confirm with the team
  • Site JP00021
    Kanagawa
    Site status: Not listed — confirm with the team
  • Site JP00022
    Kanagawa
    Site status: Not listed — confirm with the team
  • Site JP00023
    Kanagawa
    Site status: Not listed — confirm with the team
  • Site JP00024
    Kanagawa
    Site status: Not listed — confirm with the team
  • Site JP00025
    Kanagawa
    Site status: Not listed — confirm with the team
  • Site JP00042
    Kumamoto
    Site status: Not listed — confirm with the team
  • Site JP00050
    Kumamoto
    Site status: Not listed — confirm with the team
  • Site JP00032
    Kyoto
    Site status: Not listed — confirm with the team
  • Site JP00084
    Kyoto
    Site status: Not listed — confirm with the team
  • Site JP00077
    Miyagi
    Site status: Not listed — confirm with the team
  • Site JP00027
    Nagano
    Site status: Not listed — confirm with the team
  • Site JP00075
    Nara
    Site status: Not listed — confirm with the team
  • Site JP00054
    Okayama
    Site status: Not listed — confirm with the team
  • Site JP00079
    Okayama
    Site status: Not listed — confirm with the team
  • Site JP00043
    Okinawa
    Site status: Not listed — confirm with the team
  • Site JP00046
    Okinawa
    Site status: Not listed — confirm with the team
  • Site JP00033
    Osaka
    Site status: Not listed — confirm with the team
  • Site JP00034
    Osaka
    Site status: Not listed — confirm with the team
  • Site JP00047
    Osaka
    Site status: Not listed — confirm with the team
  • Site JP00063
    Osaka
    Site status: Not listed — confirm with the team
  • Site JP00053
    Ōita
    Site status: Not listed — confirm with the team
  • Site JP00029
    Shizuoka
    Site status: Not listed — confirm with the team
  • Site JP00036
    Tokushima
    Site status: Not listed — confirm with the team
  • Site JP00010
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00011
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00012
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00013
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00014
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00015
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00016
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00017
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00018
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00019
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00020
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00045
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00048
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00051
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00057
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00060
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00064
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00065
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00066
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00070
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00071
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00078
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00081
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00085
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00086
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00087
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00088
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00089
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00090
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00093
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00099
    Tokyo
    Site status: Not listed — confirm with the team
  • Site JP00044
    Tottori
    Site status: Not listed — confirm with the team
  • Site JP00026
    Toyama
    Site status: Not listed — confirm with the team

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Study ID: NCT01725308. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving FK949E, Placebo. Phase 2 studies usually explore whether the intervention may work, while continuing to monitor safety.

Who might this study be for?

This study may concern people with bipolarity; age range: From 20 Years to 64 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Astellas Pharma Inc, which appears to be a pharmaceutical company. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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