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Study to Evaluate Safety and Tolerability of FK949E in Elderly Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01903200
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation of quetiapine) in elderly patients with major depressive disorder (MDD).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Patients Drug: FK949E Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase I Study of FK949E - Multiple Dose Study of Elderly Adult Patients With Major Depressive Disorder
Study Start Date : February 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Quetiapine

Arm Intervention/treatment
Experimental: FK949E Fed Group
FK949E is administered after breakfast
Drug: FK949E
Oral
Other Name: extended release formulation of quetiapine

Experimental: FK949E Fasted Group
FK949E is administered in the morning under fasting conditions
Drug: FK949E
Oral
Other Name: extended release formulation of quetiapine




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of unchanged quetiapine [ Time Frame: For 24 hours after dosing. ]
  2. AUC (area under the curve) of unchanged quetiapine [ Time Frame: For 24 hours after dosing. ]

Secondary Outcome Measures :
  1. tmax of plasma concentration of unchanged quetiapine [ Time Frame: For 24 hours after dosing. ]
  2. t1/2 of plasma concentration of unchanged quetiapine [ Time Frame: For 24 hours after dosing. ]
  3. Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam [ Time Frame: Up to 25 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of major depressive disorder according to the DSM-IV-TR (Text Revision of the Diagnostic and Statistical Manual of Mental Disorders version-4) criteria for any of the following:

    • In case of not receiving antidepressant treatment: Patients with a diagnosis within 6 months prior to provision of written informed consent
    • In case of receiving antidepressant treatment: Patients continuously receiving antidepressant treatment at the time of providing written informed consent
  • Female patients of childbearing potential with a negative serum pregnancy test result and who were willing and able to use a reliable method of birth control during the study
  • Patients who could understand and comply with the requirements of the study, as judged by the investigator/sub-investigator

Exclusion Criteria:

  • A current or past history of a DSM-IV-TR Axis I disorder other than major depressive disorder within 6 months prior to the study
  • Diagnosis of a DSM-IV-TR Axis II disorder that was considered to have a major impact on the patient's current psychiatric status
  • A history of substance or alcohol abuse or dependence excluding caffeine and nicotine
  • Patients who were unable to abstain from drugs that induce or inhibit the drug-metabolizing enzyme CYP3A4 from 14 days prior to the start of study drug administration and throughout the study period
  • Patients showing evidence or signs of renal or hepatic failure, serious heart disease, cerebrovascular disease, viral hepatitis B or C, or acquired immunodeficiency syndrome (AIDS) (carrier)
  • Patients with any diagnosis of a neurological condition, such as Parkinson's disease, Huntington's disease, essential tremor, multiple sclerosis, prior brain injury, space occupying lesion, etc.
  • A clinical finding that is unstable (e.g., hypertension, unstable angina) or that, in the opinion of the investigator or sub-investigator, would be negatively affected by the study medication or that would affect the study medication
  • A current diagnosis of cancer (except basal or squamous cell skin carcinoma), unless it has been in remission for at least 5 years.
  • Conditions that could affect absorption and metabolism of study medication (e.g., malabsorption syndrome, liver disease).
  • A current or past diagnosis of transient ischemic attack (TIA)
  • A history of seizure disorder, except for febrile convulsions
  • Receipt of electroconvulsive therapy within 90 days prior to the start of study drug administration
  • Use of a depot antipsychotic injection and inability to be off the drug for a period of twice the dosing interval prior to the start of study drug administration and throughout the study period
  • Patients who, in the investigator's opinion, would require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy had been ongoing for a minimum of 90 days

before study drug administration

  • A score of ≥ 3 on the HAM-D17 Item (suicide) or a suicide attempt within the past 6 months, and those judged to be at serious suicidal or homicidal risk in the opinion of the investigator/sub-investigator
  • A current or past history of diabetes mellitus* or glycated hemoglobin (HbA1c) of ≥ 6.5% at screening within 2 months before the start of study drug administration (*refer to the guidelines for monitoring blood glucose levels in patients treated with atypical antipsychotics)
  • A white blood cell count (WBC) of ≤ 3,000/mm3 at screening assessment
  • Elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values at screening assessment (grade 2 or higher according to the "Criteria for Classification of the Grade of Adverse Drug Reactions to Pharmaceutical Products" (Pharmaceutical Affairs Bureau Safety Division's Notification No. 80 issued on 29 June 1992))
  • A known history of hypersensitivity to quetiapine or to any other component in the FK949E tablets at the time of providing written informed consent
  • Treatment with quetiapine for depressive symptoms or bipolar disorder (mania) at the time of providing written informed consent
  • Participation in another clinical study or post-marketing study within 12 weeks prior to the start of study drug administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903200


Locations
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Japan
Kansai, Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc

Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01903200     History of Changes
Other Study ID Numbers: 6949-CL-0002
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Keywords provided by Astellas Pharma Inc:
Antipsychotic
FK949E
Quetiapine
Elderly

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs