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Trial record 18 of 450 for:    QUETIAPINE

Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines

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.
 
ClinicalTrials.gov Identifier: NCT01244711
Recruitment Status : Terminated (Terminated: recruiting or enrolling participants has halted prematurely)
First Posted : November 19, 2010
Results First Posted : March 6, 2015
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Major Depression
Generalized Anxiety Disorder
Intervention Drug: quetiapine
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quetiapine
Hide Arm/Group Description

Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Quetiapine
Hide Arm/Group Description

Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
48
(48 to 48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Montgomery Asberg Depression Rating Scale (MADRS)
Hide Description For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week. Range is 0 (least severe) to 50 (most severe).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Change in total score on the MADRS from baseline to final visit
Arm/Group Title Quetiapine
Hide Arm/Group Description:

Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
-12
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine
Hide Arm/Group Description

Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.

All-Cause Mortality
Quetiapine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Quetiapine
Affected / at Risk (%)
Total   0/1 (0.00%) 
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: james kocsis
Organization: Weill Cornell Medical College
Phone: 212-746-5913
EMail: jhk2002@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01244711     History of Changes
Other Study ID Numbers: IRUSQUET0483
First Submitted: November 18, 2010
First Posted: November 19, 2010
Results First Submitted: December 18, 2014
Results First Posted: March 6, 2015
Last Update Posted: April 3, 2015