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

NCT01725282 | Completed Phase 2 Results

• 1 other identifier: 6949-CL-0005
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 3

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

Keywords

patients; FK949E

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.

  Baseline and Week 6

Secondary Outcomes (5)

• Change From Baseline in Hamilton Rating Score for Depression (HAM-D17)

  Baseline and Week 6

• Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I)

  Baseline and Week 6

• Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)

  Baseline and Week 6

• Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)

  Baseline and Week 6

• Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests

  Up to 8 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Quetiapine 50 mg

EXPERIMENTAL

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

Drug: quetiapine extended release (XR)

Quetiapine 150 mg

EXPERIMENTAL

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.

Drug: quetiapine extended release (XR)

Quetiapine 300 mg

EXPERIMENTAL

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.

Drug: quetiapine extended release (XR)

Interventions

quetiapine extended release (XR) DRUG

Extended release tablets

Also known as: Seroquel XR, FK949E

Quetiapine 150 mg; Quetiapine 300 mg; Quetiapine 50 mg

Placebo DRUG

matching tablets

Placebo

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (3)

Unknown Facility

Hokkaidou, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kinki, Japan

Location

Related Publications (1)

• 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.

  PMID: 32792252 DERIVED

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Vice President, Clinical Development Administration
• Organization: Astellas Pharma Inc.

clinicaltrials@us.astellas.com

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 12, 2012
• Study Start: December 14, 2011
• Primary Completion: August 24, 2013
• Study Completion: August 24, 2013
• Last Updated: November 15, 2024
• Results First Posted: August 28, 2014

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

JP (3)