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Trial record 27 of 450 for:    QUETIAPINE

Brain Imaging of Quetiapine Response in Anxious Depression

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ClinicalTrials.gov Identifier: NCT00982345
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depression
Intervention Drug: quetiapine (Seroquel XR)
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Seroquel XR
Hide Arm/Group Description Seroquel XR (quetiapine) starting dose 50 mg and increased up to 400 mg as tolerated) treatment.
Period Title: Overall Study
Started 20
Completed 18
Not Completed 2
Arm/Group Title Quetiapine
Hide Arm/Group Description quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
29  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
12
  60.0%
Male
8
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title 17-item Hamilton Depression Rating Scale (HDRS)
Hide Description Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.
Time Frame Started: March 2009 Ending March 2011
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine
Hide Arm/Group Description:
quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17-item HDRS 20  (3)
Post-treatment at 8 weeks 17-item HDRS 8  (6)
Time Frame Adverse event data were collected for 12 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine
Hide Arm/Group Description quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
All-Cause Mortality
Quetiapine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine
Affected / at Risk (%)
Total   18/20 (90.00%) 
Gastrointestinal disorders   
indigestion   2/20 (10.00%) 
constipation   6/20 (30.00%) 
increased appetite   5/20 (25.00%) 
abdominal pain   4/20 (20.00%) 
nausea   3/20 (15.00%) 
increased thirst   1/20 (5.00%) 
decreased appetite   2/20 (10.00%) 
DIARRHEA   1/20 (5.00%) 
Nervous system disorders   
fatigue   16/20 (80.00%) 
Irritability   3/20 (15.00%) 
dizziness   7/20 (35.00%) 
increased sleep   15/20 (75.00%) 
headache   4/20 (20.00%) 
dry mouth   12/20 (60.00%) 
blurred vision   1/20 (5.00%) 
decreased sleep   2/20 (10.00%) 
twitching   3/20 (15.00%) 
sweating   2/20 (10.00%) 
tremor   1/20 (5.00%) 
fainting   1/20 (5.00%) 
Renal and urinary disorders   
urinary frequency   2/20 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
shortness of breath   1/20 (5.00%) 
nose congestion   1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
hand dryness   1/20 (5.00%) 
hives   1/20 (5.00%) 
Vascular disorders   
fluid retention   1/20 (5.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amit Anand
Organization: Indiana University
Phone: 317-274-7422
EMail: aanand@iupui.edu
Layout table for additonal information
Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00982345     History of Changes
Other Study ID Numbers: 0901-13
First Submitted: September 21, 2009
First Posted: September 23, 2009
Results First Submitted: October 7, 2013
Results First Posted: September 30, 2016
Last Update Posted: September 30, 2016