A Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive Episodes

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01725308
First received: November 8, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

In period I, the treatment effect of FK949E will be compared with that of placebo in a blind manner in bipolar disorder patients with major depressive episodes. In period II, long-term safety and efficacy of FK949E will be evaluated.


Condition Intervention Phase
Bipolar Disorder
Drug: FK949E
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 —

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: Baseline, at 8 weeks after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MADRS [ Time Frame: Baseline, at 8 weeks after dosing ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale (HAM-D17) [ Time Frame: Baseline, at 8 weeks after dosing ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Bipolar-Severity (CGI-BP-S) [ Time Frame: Baseline, at 8 weeks after dosing ] [ Designated as safety issue: No ]
    (Mania, Depression and Overall)

  • Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and Labo-tests [ Time Frame: for 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: December 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period I FK949E Drug: FK949E
Oral
Other Name: quetiapine
Placebo Comparator: Period I placebo Drug: Placebo
Oral
Experimental: Period II FK949E
Patients who completed the treatment Period I
Drug: FK949E
Oral
Other Name: quetiapine

Detailed Description:

This study consists of two part. In Treatment Period I, FK949E or placebo will be administered orally in a blind manner to bipolar disorder patients with major depressive episodes, with the aim of evaluating the superiority of FK949 over placebo and the dose response of two doses of FK949E based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) total score. In Treatment Period II, the long-term safety, efficacy and parmacokinetics of FK949E will be evaluated in patients who have participated in the study and completed the Treatment Period I.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of bipolar I or II disorder as specified in the DSM-IV-TR, with a major depressive episode
  • The Hamilton Depression Rating Scale (HAM-D17) total score of 20 points or more and HAM-D17 depressed mood score of 2 points or more
  • Able to participate in the study with understanding of and compliance with subject requirements during the study in the investigator's or subinvestigator's opinion

Exclusion Criteria:

  • Concurrent or previous history of DSM-IV-TR Axis I disorders, except bipolar disorder, within the last 6 months before informed consent
  • Concurrence of DSM-IV-TR Axis II disorder that is considered to greatly affect patient's current mental status
  • The Young Mania Rating Scale (YMRS) total score of 13 points or more
  • Nine or more mood episodes within the last 12 months before informed consent
  • Lack of response to at least 6-week treatment with at least 2 antidepressants for the current major depressive episode in the investigator's or subinvestigator's opinion
  • History of abuse or dependence of alcohol or substances other than caffeine and nicotine
  • Treatment with a depot antipsychotic within the last 42 days before primary registration
  • Unable to suspend mood stabilizers (lithium carbonate and/or sodium valproate), lamotrigine, antipsychotics, or antidepressants from 7 days before secondary registration
  • Unable to suspend antiepileptics (except lamotrigine and sodium valproate), antianxiety agents, hypnotics, sedatives, psychostimulants, antiparkinsonian agents, cerebral ameliorators, antidementia agents, or anorectics, except those specified as conditionally-allowed concomitant drugs, after primary registration
  • Electroconvulsive therapy within the last 76 days before primary registration
  • The current major depressive episode persisting for more than 12 months or less than 4 weeks before informed consent
  • A possible need of psychotherapy during the study period (unless the therapy has been commenced at least 76 days before primary registration and been maintained on a fixed level at fixed frequency)
  • Documented or suspected conditions such as renal failure, hepatic failure, serious cardiac disease, hepatitis B, hepatitis C, or acquired immunodeficiency syndrome (AIDS) (or to be a carrier of hepatitis B, hepatitis C, or AIDS)
  • Concurrence of malignancy or history of cured malignancy within 5 years
  • Concurrence of uncontrolled hypertension (defined as a systolic blood pressure of 180 mmHg or more, or a diastolic blood pressure of 110 mmHg or more at primary registration) or unstable angina that may worsen with the study or may affect the study results based on the clinical judgment of the investigator or sub-investigator
  • Concurrence of hypotension (defined as a systolic blood pressure of less than 100 mmHg at primary registration) or orthostatic hypotension
  • History of transient, idiopathic orthostatic hypotension, with or without pre-syncope symptoms or syncope, or a current condition susceptible to transient hypotension, such as dehydration and decreased blood volume
  • Concurrent or previous history of cerebrovascular disease or transient ischemic attack (TIA)
  • Abnormal laboratory or electrocardiographic findings considered clinically significant in the investigator's or subinvestigator's opinion (in reference to grade 3 of the Adverse Drug Reactions Severity Grading Criteria [Notification No. 80 of the Safety Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare dated 29 June 1992])
  • Participation in another clinical study or post-marketing study within the last 12 weeks before informed consent
  • History of quetiapine therapy during the current major depressive episode
  • Pregnant or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725308

Contacts
Contact: Clinical Development Administration Dept. clinicaltrials_info@jp.astellas.com

Locations
Japan
Recruiting
Chubu, Japan
Recruiting
Chugoku, Japan
Recruiting
Hokkaido, Japan
Recruiting
Kansai, Japan
Recruiting
Kanto, Japan
Recruiting
Kyushu, Japan
Recruiting
Shikoku, Japan
Recruiting
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01725308     History of Changes
Other Study ID Numbers: 6949-CL-0021
Study First Received: November 8, 2012
Last Updated: January 22, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
FK949E
Major depressive episode
patients

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 24, 2014