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

Astellas

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: quetiapine extended release (XR); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01725282

6949-CL-0005

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Quetiapine 50 mg

Experimental group

Description:

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

Treatment:

Drug: quetiapine extended release (XR)

Quetiapine 150 mg

Experimental group

Description:

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.

Treatment:

Drug: quetiapine extended release (XR)

Quetiapine 300 mg

Experimental group

Description:

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.

Treatment:

Drug: quetiapine extended release (XR)