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Trial record 46 of 1671 for:    depression AND Major Depression AND Scale | "Depression"

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

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ClinicalTrials.gov Identifier: NCT01725282
Recruitment Status : Completed
First Posted : November 12, 2012
Results First Posted : August 28, 2014
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: quetiapine extended release (XR)
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants received matching placebo tablets once daily before bedtime for 7 weeks.
Quetiapine 50 mg Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
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.
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.

Participant Flow:   Overall Study
    Placebo   Quetiapine 50 mg   Quetiapine 150 mg   Quetiapine 300 mg
STARTED   44   44   41   43 
COMPLETED   42   39   33   36 
NOT COMPLETED   2   5   8   7 
Adverse Event                1                3                6                4 
Exacerbation of Target Disease                1                0                0                1 
Met Exclusion Criteria                0                0                1                0 
Study Site Withdrawal                0                1                0                0 
Withdrawal by Subject                0                0                1                1 
Lack of Efficacy                0                1                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received matching placebo tablets once daily before bedtime for 7 weeks.
Quetiapine 50 mg Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
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.
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.
Total Total of all reporting groups

Baseline Measures
   Placebo   Quetiapine 50 mg   Quetiapine 150 mg   Quetiapine 300 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   44   41   43   172 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.8  (11.2)   39.0  (9.5)   35.2  (8.6)   37.3  (9.7)   37.9  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      19  43.2%      15  34.1%      17  41.5%      17  39.5%      68  39.5% 
Male      25  56.8%      29  65.9%      24  58.5%      26  60.5%      104  60.5% 
Region of Enrollment 
[Units: Participants]
         
Japan   44   44   41   43   172 
Montgomery Åsberg Depression Rating Scale (MADRS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 28.5  (5.1)   28.7  (5.9)   29.0  (5.4)   29.3  (5.4)   28.9  (5.4) 
[1] MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
Hamilton Depression Scale 17-Item (HAM D17) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 22.6  (2.3)   22.6  (2.4)   23.3  (3.0)   22.9  (2.5)   22.8  (2.6) 
[1] 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 ranges from 0 to 52, where a higher score indicates a greater depressive state.


  Outcome Measures

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

2.  Secondary:   Change From Baseline in Hamilton Rating Score for Depression (HAM-D17)   [ Time Frame: Baseline and Week 6 ]

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

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

5.  Secondary:   Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: Baseline and Week 6 ]

6.  Secondary:   Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests   [ Time Frame: Up to 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Clinical Development Administration
Organization: Astellas Pharma Inc.
e-mail: clinicaltrials@us.astellas.com



Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01725282     History of Changes
Other Study ID Numbers: 6949-CL-0005
First Submitted: November 8, 2012
First Posted: November 12, 2012
Results First Submitted: August 14, 2014
Results First Posted: August 28, 2014
Last Update Posted: March 21, 2017