Study to Evaluate the Effect and Safety of FK949E in Major Depressive Disorder Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01725282
First received: November 8, 2012
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

In this study, FK949E or placebo will be administered orally for 6 weeks to major depressive disorder patients with lack of response to existing antidepressants, with the aim of evaluating the efficacy of FK949E and dose-response in the three FK949E dose groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores. The safety and pharmacokinetics of FK949E will also be evaluated.


Condition Intervention Phase
Major Depressive Disorder
Drug: FK949E
Drug: Placebo
Phase 2

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 Study of FK949E -Placebo-controlled, Double-blind, Parallel-group Comparative Study in Major Depressive Disorder Patients With Lack of Response to Existing Antidepressants-

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Changes in Montgomery-Asberg Depression Rating Scale (MADRS) total scores [ Time Frame: Baseline and the final assessment point during the treatment period. Treatment period is for 6 weeks. ] [ Designated as safety issue: No ]
    Montgomery-Asberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire to measure the severity of depressive episodes in patients with mood disorders.


Secondary Outcome Measures:
  • Hamilton Rating Score for Depression (HAM-D17) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    HAM-D17 is to rate the severity of depression in who are already diagnosed as depressed. The higher the score, the more severe the depression.

  • Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, vital signs, 12-lead ECG and labo-tests [ Time Frame: During the treatment (for 6 weeks) and dose-tapering period (+ 7 days). ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: November 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FK949E low dose Drug: FK949E
oral
Other Name: quetiapine
Experimental: FK949E middle dose Drug: FK949E
oral
Other Name: quetiapine
Experimental: FK949E high dose Drug: FK949E
oral
Other Name: quetiapine
Placebo Comparator: Placebo Drug: Placebo
oral

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of major depressive disorder as specified in the DSM-IV-TR with the use of the Mini-International Neuropsychiatric Interview (M.I.N.I.)
  • Documented appropriate treatment history (i.e., lack of response to treatment at labeled dosage for at least 4 weeks) for the current major depression episode with an antidepressant other than that used concomitantly with the study drug
  • 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

Exclusion Criteria:

  • Concurrent or previous history of DSM-IV-TR Axis I disorders, except major depressive 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 duration of the current major depression episode is shorter than 4 weeks or longer than 24 months at informed consent
  • History of dependence of substances other than caffeine and nicotine or history of abuse or dependence of alcohol
  • The HAM-D17 suicide score of 3 points or more, history of suicide attempt within the last 6 months before informed consent, or the risk of suicide in the investigator's or subinvestigator's opinion
  • Concurrent or previous history of diabetes mellitus. HbA1c levels of 6.1% (JDS values) or more within the past 2 months
  • Electroconvulsive therapy within the last 62 days before primary registration (within the last 90 days before secondary registration)
  • Treatment with a depot antipsychotic within the last 28 days
  • Documented or suspected (to be a carrier of) conditions such as renal failure, hepatic failure, serious cardiac disease (or current use of antiarrhythmic drugs), hepatitis B, hepatitis C, or acquired immunodeficiency syndrome (AIDS)
  • 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 subinvestigator
  • Concurrence of hypotension (defined as a systolic blood pressure of less than 100 mmHg at primary registration) or orthostatic hypotension
  • Concurrence of malabsorption syndrome, hepatic disease, or other conditions that may affect the absorption and/or metabolism of the study drug
  • Concurrent or previous history of cerebrovascular disease or transient ischemic attack (TIA)
  • Known hypersensitivity to quetiapine or any component of FK949E tablets
  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: NCT01725282

Locations
Japan
Hokkaidou, Japan
Kantou, Japan
Kinki, 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: NCT01725282     History of Changes
Other Study ID Numbers: 6949-CL-0005
Study First Received: November 8, 2012
Last Updated: April 25, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
FK949E
patients

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

ClinicalTrials.gov processed this record on August 21, 2014