Major Depressive Disorder Patients Clinical Trial
Official title:
Phase I Study of FK949E - Multiple Dose Study of Elderly Adult Patients With Major Depressive Disorder
| Verified date | February 2017 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum plasma concentration (Cmax) of unchanged quetiapine | For 24 hours after dosing. | ||
| Primary | AUC (area under the curve) of unchanged quetiapine | For 24 hours after dosing. | ||
| Secondary | tmax of plasma concentration of unchanged quetiapine | For 24 hours after dosing. | ||
| Secondary | t1/2 of plasma concentration of unchanged quetiapine | For 24 hours after dosing. | ||
| Secondary | Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam | Up to 25 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01871974 -
Study to Evaluate Safety and Tolerability of FK949E in Patients With Major Depressive Disorder
|
Phase 1 |