Clinical trial NCT01924520: Oral Multiple-dose Study in Patients With Major Depressive Disorder
Official title: Phase I Study of FK949E - Phase I Oral Multiple-dose Study in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: Antipsychotic
FK949E
Quetiapine
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-08-16
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).

Detailed description: The objective of the study was to evaluate the safety and pharmacokinetics of multiple oral doses of FK949E (extended-release formulation of quetiapine) of three doses in patients with major depressive disorder (MDD).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of major depressive disorder by the M.I.N.I. according to the DSM-IV-TR
* 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 provision of written informed consent.
* 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 screening assessment 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 being treated for hypertension or patients with clinical finding that in the opinion of the investigator/sub-investigator could be negatively affected by the study or that would affect the study results (e.g., hypertension, unstable angina).
* Patients with concomitant hypotension or orthostatic hypotension (hypotension is defined as systolic blood pressure of less than 100 mmHg)
* Conditions that could affect absorption and metabolism of the study medication (e.g., malabsorption syndrome, liver disease)
* A current diagnosis of malignant tumor unless in remission for at least 5 years (except basal or squamous cell skin carcinoma).
* A history of transient ischemic attack (TIA).
* A history of seizure disorder, except for febrile convulsions
* Application 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 screening assessment and throughout the study period
* A score of ≥ 3 on the HAM-D17 Item (suicide) or a suicide attempt within the past 6 months. Patients judged to be at serious suicidal or homicidal risk in the opinion of the investigator/sub-investigator.

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of unchanged quetiapine
timeFrame: for 24 hours after dosing
measure: AUC24h (area under the curve for 24hr) of unchanged quetiapine
timeFrame: for 24 hours after dosing
Secondary outcomes:
measure: trough value of plasma concentration of unchanged quetiapine
timeFrame: for 24 hours after dosing
measure: t1/2 of plasma concentration of unchanged quetiapine
timeFrame: for 24 hours after dosing
measure: Maximum plasma concentration (Cmax) of quetiapine metabolites
timeFrame: for 24 hours after dosing
measure: AUC (area under the curve) of quetiapine metabolites
timeFrame: for 24 hours after dosing
measure: trough value of plasma concentration of quetiapine metabolites
timeFrame: for 24 hours after dosing
measure: tmax of plasma concentration of quetiapine metabolites
timeFrame: for 24 hours after dosing
measure: t1/2 of plasma concentration of quetiapine metabolites
timeFrame: for 24 hours after dosing
measure: Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam
timeFrame: Up to Day 14
Other outcomes:
Locations:
city: Kansai
country: Japan
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: