Study to Evaluate the Effect and Safety of Quetiapine Extended Release (XR) (FK949E) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: quetiapine extended release (XR); Placebo
Intervention description: Extended release tablets; matching tablets
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: patients; FK949E

Summary:

      In this study, quetiapine XR 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 quetiapine XR and dose-response in three quetiapine XR dose
      groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of major depressive disorder as specified in the Diagnostic and Statistical
             Manual of Mental Disorders, 4th edition, Text Revision (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% (Japan
             Diabetes Society 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