Study Details

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A study to evaluate the efficacy of FK949E in Bipolar Disorder patients with Major Depressive Episodes

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01725308

Astellas Study ID

The unique identification code given by the study sponsor.

6949-CL-0021

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Follow Trial

Condition

Bipolar Disorder/Depression

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

20 years - 64 years

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Feb 2012 - Jul 2016

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

431

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

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site JP00077

Miyagi, Japan

Site JP00069

Hokkaido, Japan

Site JP00005

Ibaraki, Japan

Site JP00020

Tokyo, Japan

Site JP00001

Hokkaido, Japan

Site JP00031

Aichi, Japan

Site JP00064

Tokyo, Japan

Site JP00095

Fukuoka, Japan

Site JP00056

Hiroshima, Japan

Site JP00011

Tokyo, Japan

Site JP00049

Kagawa, Japan

Site JP00090

Tokyo, Japan

Site JP00039

Fukuoka, Japan

Site JP00004

Fukushima, Japan

Site JP00022

Kanagawa, Japan

Site JP00070

Tokyo, Japan

Site JP00086

Tokyo, Japan

Site JP00047

Osaka, Japan

Site JP00096

Fukuoka, Japan

Site JP00092

Aichi, Japan

Site JP00034

Osaka, Japan

Site JP00040

Fukuoka, Japan

Site JP00010

Tokyo, Japan

Site JP00067

Hiroshima, Japan

Site JP00051

Tokyo, Japan

Site JP00057

Tokyo, Japan

Site JP00053

Oita, Japan

Site JP00087

Tokyo, Japan

Site JP00043

Okinawa, Japan

Site JP00052

Aichi, Japan

Site JP00037

Fukuoka, Japan

Site JP00066

Tokyo, Japan

Site JP00030

Aichi, Japan

Site JP00042

Kumamoto, Japan

Site JP00013

Tokyo, Japan

Site JP00008

Chiba, Japan

Site JP00023

Kanagawa, Japan

Site JP00065

Tokyo, Japan

Site JP00061

Hokkaido, Japan

Site JP00063

Osaka, Japan

Site JP00018

Tokyo, Japan

Site JP00038

Fukuoka, Japan

Site JP00045

Tokyo, Japan

Site JP00044

Tottori, Japan

Site JP00048

Tokyo, Japan

Site JP00029

Shizuoka, Japan

Site JP00002

Fukuoka, Japan

Site JP00014

Tokyo, Japan

Site JP00073

Hokkaido, Japan

Site JP00097

Fukuoka, Japan

Site JP00091

Fukuoka, Japan

Site JP00033

Osaka, Japan

Site JP00012

Tokyo, Japan

Site JP00076

Hokkaido, Japan

Site JP00072

Aichi, Japan

Site JP00009

Chiba, Japan

Site JP00094

Fukuoka, Japan

Site JP00041

Fukuoka, Japan

Site JP00060

Tokyo, Japan

Site JP00068

Hokkaido, Japan

Site JP00098

Fukuoka, Japan

Site JP00028

Gifu, Japan

Site JP00035

Hiroshima, Japan

Site JP00075

Nara, Japan

Site JP00089

Tokyo, Japan

Site JP00006

Gunma, Japan

Site JP00093

Tokyo, Japan

Site JP00019

Tokyo, Japan

Site JP00071

Tokyo, Japan

Site JP00054

Okayama, Japan

Site JP00059

Hokkaido, Japan

Site JP00081

Tokyo, Japan

Site JP00078

Tokyo, Japan

Site JP00084

Kyoto, Japan

Site JP00088

Tokyo, Japan

Site JP00032

Kyoto, Japan

Site JP00003

Akita, Japan

Site JP00025

Kanagawa, Japan

Site JP00062

Hokkaido, Japan

Site JP00099

Tokyo, Japan

Site JP00074

Hokkaido, Japan

Site JP00015

Tokyo, Japan

Site JP00027

Nagano, Japan

Site JP00058

Fukuoka, Japan

Site JP00024

Kanagawa, Japan

Site JP00046

Okinawa, Japan

Site JP00050

Kumamoto, Japan

Site JP00017

Tokyo, Japan

Site JP00079

Okayama, Japan

Site JP00016

Tokyo, Japan

Site JP00083

Fukuoka, Japan

Site JP00021

Kanagawa, Japan

Site JP00082

Fukuoka, Japan

Site JP00007

Gunma, Japan

Site JP00055

Aichi, Japan

Site JP00085

Tokyo, Japan

Site JP00026

Toyama, Japan

Site JP00036

Tokushima, Japan

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