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

NCT ID: NCT01903200

Last Updated: 2017-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-09-30

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).

Conditions

Major Depressive Disorder Patients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

FK949E Fed Group

FK949E is administered after breakfast

Group Type: EXPERIMENTAL

FK949E

Intervention Type: DRUG

Oral

FK949E Fasted Group

FK949E is administered in the morning under fasting conditions

Group Type: EXPERIMENTAL

FK949E

Intervention Type: DRUG

Oral

Interventions

FK949E

Oral

Intervention Type: DRUG

Other Intervention Names

extended release formulation of quetiapine

Eligibility 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Kansai, , Japan

Kantou, , Japan

Countries

Japan

Related Links

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=176

Link to results on Astellas Clinical Study Results website

Other Identifiers

6949-CL-0002

Identifier Type: -

Identifier Source: org_study_id