Working… Menu
Trial record 93 of 1317 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND weeks

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01725282
Recruitment Status : Completed
First Posted : November 12, 2012
Results First Posted : August 28, 2014
Last Update Posted : July 30, 2019
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: quetiapine extended release (XR) Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of FK949E - Double-blind, Placebo-controlled, Comparative Study in Major Depressive Disorder Patients With Inadequate Response to Existing Antidepressants
Actual Study Start Date : December 14, 2011
Actual Primary Completion Date : August 24, 2013
Actual Study Completion Date : August 24, 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received matching placebo tablets once daily before bedtime for 7 weeks.
Drug: Placebo
matching tablets

Experimental: Quetiapine 50 mg
Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
Drug: quetiapine extended release (XR)
Extended release tablets
Other Names:
  • Seroquel XR
  • FK949E

Experimental: 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.
Drug: quetiapine extended release (XR)
Extended release tablets
Other Names:
  • Seroquel XR
  • FK949E

Experimental: 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.
Drug: quetiapine extended release (XR)
Extended release tablets
Other Names:
  • Seroquel XR
  • FK949E

Primary Outcome Measures :
  1. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline and Week 6 ]
    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.

Secondary Outcome Measures :
  1. Change From Baseline in Hamilton Rating Score for Depression (HAM-D17) [ Time Frame: Baseline and Week 6 ]
    The 17-item Hamilton Depression Scale (HAM-D17) is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 52 where a higher score indicates a greater depressive state.

  2. Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Baseline and Week 6 ]

    The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, markedly improved; 2, moderately improved; 3, minimally improved; 4, no change; 5, minimally worsened; 6, moderately worsened; or 7, markedly worsened.

    Improvement is defined as a score of 1 or 2.

  3. Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Baseline and Week 6 ]

    The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are:

    1. Limitation in physical activities because of health problems.
    2. Limitations in usual role activities because of physical health problems.
    3. Bodily pain.
    4. Limitations in social activities because of physical or emotional problems.
    5. General mental health (psychological distress and well-being).
    6. Limitations in usual role activities because of emotional problems.
    7. Vitality (energy and fatigue).
    8. General health perception.

    Each scale ranges from 0 to 100, with 0 indicating the least favorable status and 100 being the most favorable health status.

  4. Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and Week 6 ]
    The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each on a scale from 0 (best) to 3 (worst). The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicative of poor sleep quality.

  5. Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests [ Time Frame: Up to 8 weeks ]
    An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have a causal relationship with this treatment. Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01725282

Layout table for location information
Hokkaidou, Japan
Kantou, Japan
Kinki, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Layout table for investigator information
Study Director: Medical Director Astellas Pharma Inc

Additional Information:
Layout table for additonal information
Responsible Party: Astellas Pharma Inc Identifier: NCT01725282     History of Changes
Other Study ID Numbers: 6949-CL-0005
First Posted: November 12, 2012    Key Record Dates
Results First Posted: August 28, 2014
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
Keywords provided by Astellas Pharma Inc:
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs