Study to Evaluate the Effect and Safety of Quetiapine Extended Release (XR) (FK949E) in Major Depressive Disorder

NCT ID: NCT01725282

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-14
• Study Completion Date: 2013-08-24

Brief 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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants received matching placebo tablets once daily before bedtime for 7 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching tablets

Quetiapine 50 mg

Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.

Group Type: EXPERIMENTAL

quetiapine extended release (XR)

Intervention Type: DRUG

Extended release tablets

Quetiapine 150 mg

After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.

Group Type: EXPERIMENTAL

quetiapine extended release (XR)

Intervention Type: DRUG

Extended release tablets

Quetiapine 300 mg

After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.

Group Type: EXPERIMENTAL

quetiapine extended release (XR)

Intervention Type: DRUG

Extended release tablets

Interventions

quetiapine extended release (XR)

Extended release tablets

Intervention Type: DRUG

Placebo

matching tablets

Intervention Type: DRUG

Other Intervention Names

Seroquel XR; FK949E

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Hokkaidou, , Japan

Kantou, , Japan

Kinki, , Japan

Countries

Japan

References

Fukushi R, Nomura Y, Katashima M, Komatsu K, Sato Y, Takada A. Approach to Evaluating QT Prolongation of Quetiapine Fumarate in Late Stage of Clinical Development Using Concentration-QTc Modeling and Simulation in Japanese Patients With Bipolar Disorder. Clin Ther. 2020 Aug;42(8):1483-1493.e1. doi: 10.1016/j.clinthera.2020.06.002. Epub 2020 Aug 11.

Reference Type: DERIVED

PMID: 32792252 (View on PubMed)

Related Links

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=180

Link to results on Astellas Clinical Study Results website

Other Identifiers

6949-CL-0005

Identifier Type: -

Identifier Source: org_study_id