Oral Multiple-dose Study in Patients With Major Depressive Disorder

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

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: FK949E

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).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kansai, Japan
  • Kantou, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (FK949E lower dose); Oral	Drug: FK949E; Oral; Other Names: extended-release formulation of quetiapine
Experimental: Group 2 (FK949E middle dose); Oral	Drug: FK949E; Oral; Other Names: extended-release formulation of quetiapine
Experimental: Group 3 (FK949E higher dose); Oral	Drug: FK949E; Oral; Other Names: extended-release formulation of quetiapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax) of unchanged quetiapine	for 24 hours after dosing
AUC24h (area under the curve for 24hr) of unchanged quetiapine	for 24 hours after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
trough value of plasma concentration of unchanged quetiapine	for 24 hours after dosing
t1/2 of plasma concentration of unchanged quetiapine	for 24 hours after dosing
Maximum plasma concentration (Cmax) of quetiapine metabolites	for 24 hours after dosing
AUC (area under the curve) of quetiapine metabolites	for 24 hours after dosing
trough value of plasma concentration of quetiapine metabolites	for 24 hours after dosing
tmax of plasma concentration of quetiapine metabolites	for 24 hours after dosing
t1/2 of plasma concentration of quetiapine metabolites	for 24 hours after dosing
Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam	Up to Day 14

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 14, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Antipsychotic; Quetiapine; FK949E
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: 6949-CL-0009