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Trial record 84 of 450 for:    QUETIAPINE

Quetiapine Extended Release (XR) Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder (MDD/GAD)

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ClinicalTrials.gov Identifier: NCT00868374
Recruitment Status : Terminated (Study terminated due to low enrollment)
First Posted : March 25, 2009
Results First Posted : February 11, 2014
Last Update Posted : December 29, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Keming Gao, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Generalized Anxiety Disorder
Interventions Drug: Quetiapine XR
Drug: Placebo
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
Period Title: Overall Study
Started 12 11
Completed 5 4
Not Completed 7 7
Arm/Group Title Quetiapine XR Placebo Total
Hide Arm/Group Description Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day Total of all reporting groups
Overall Number of Baseline Participants 12 11 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 12 participants 11 participants 23 participants
48.3  (11.3) 41.2  (6.1) 45.1  (7.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Female
9
  75.0%
9
  81.8%
18
  78.3%
Male
3
  25.0%
2
  18.2%
5
  21.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  66.7%
3
  27.3%
11
  47.8%
White
4
  33.3%
8
  72.7%
12
  52.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)
Hide Description The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25-52 indicates severe depression.
Time Frame Week 0 - Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
Overall Number of Participants Analyzed 12 11
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.5
(-22.1 to 21.1)
3.9
(-1.5 to 9.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
All-Cause Mortality
Quetiapine XR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine XR Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      1/11 (9.09%)    
Psychiatric disorders     
Suicide Attempt *  0/12 (0.00%)  0 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine XR Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/12 (91.67%)      8/11 (72.73%)    
Eye disorders     
Blurred Vision *  1/12 (8.33%)  1 0/11 (0.00%)  0
Eye Twitching *  0/12 (0.00%)  0 1/11 (9.09%)  1
Gastrointestinal disorders     
Diarrhea *  1/12 (8.33%)  1 0/11 (0.00%)  0
Nausea *  1/12 (8.33%)  1 0/11 (0.00%)  0
Vomiting *  1/12 (8.33%)  1 0/11 (0.00%)  0
Constipation *  0/12 (0.00%)  0 1/11 (9.09%)  1
Gas *  0/12 (0.00%)  0 1/11 (9.09%)  1
General disorders     
Dry Mouth *  6/12 (50.00%)  6 1/11 (9.09%)  1
Fatigue *  5/12 (41.67%)  5 3/11 (27.27%)  3
Headache *  3/12 (25.00%)  3 0/11 (0.00%)  0
Sedation *  2/12 (16.67%)  2 0/11 (0.00%)  0
Dizziness *  1/12 (8.33%)  1 2/11 (18.18%)  2
Increase Appetite *  0/12 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders     
Muscle Stiffness *  1/12 (8.33%)  1 0/11 (0.00%)  0
Psychiatric disorders     
Anxiety *  1/12 (8.33%)  1 0/11 (0.00%)  0
Irritability *  1/12 (8.33%)  1 0/11 (0.00%)  0
Insomnia *  0/12 (0.00%)  0 2/11 (18.18%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Keming Gao
Organization: University Hospitals Cleveland Medical Center
Phone: 216-844-2865
EMail: keming.gao@UHhospitals.org
Layout table for additonal information
Responsible Party: Keming Gao, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00868374     History of Changes
Other Study ID Numbers: 12-07-29
First Submitted: March 24, 2009
First Posted: March 25, 2009
Results First Submitted: November 1, 2013
Results First Posted: February 11, 2014
Last Update Posted: December 29, 2016