Oral Multiple-dose Study in Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Phase I Study of FK949E - Phase I Oral Multiple-dose Study in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924520
• Other study ID #: 6949-CL-0009
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2013
• Last updated: February 14, 2017
• Start date: November 2010
• Est. completion date: May 2011

Study information

• Verified date: February 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• FK949E
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of unchanged quetiapine		for 24 hours after dosing
Primary	AUC24h (area under the curve for 24hr) of unchanged quetiapine		for 24 hours after dosing
Secondary	trough value 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	Maximum plasma concentration (Cmax) of quetiapine metabolites		for 24 hours after dosing
Secondary	AUC (area under the curve) of quetiapine metabolites		for 24 hours after dosing
Secondary	trough value of plasma concentration of quetiapine metabolites		for 24 hours after dosing
Secondary	tmax of plasma concentration of quetiapine metabolites		for 24 hours after dosing
Secondary	t1/2 of plasma concentration of quetiapine metabolites		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 Day 14

External Links

•   Link to results on Astellas Clinical Study Results website