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Trial record 40 of 450 for:    QUETIAPINE

Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar 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.
 
ClinicalTrials.gov Identifier: NCT01195363
Recruitment Status : Completed
First Posted : September 6, 2010
Results First Posted : February 12, 2015
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Charles L. Bowden, The University of Texas Health Science Center at San Antonio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: quetiapine SR
Drug: quetiapine sr placebo
Enrollment 28
Recruitment Details Participants were recruited in our University, Center for Healthcare Services, and by televison ads between Oct 2007 and January 2011.
Pre-assignment Details Patients screened over a 7 day period.
Arm/Group Title Quetiapine SR, 200-600mg , po, QD Quetiapine sr Placebo 200-600mg, po, qd
Hide Arm/Group Description mood stabilizer plus active quetiapine SR mood stabilizer plus quetiapine SR placebo
Period Title: Overall Study
Started 15 13
Completed 4 4
Not Completed 11 9
Reason Not Completed
Lost to Follow-up             7             4
Adverse Event             3             1
Lack of Efficacy             0             4
incarceration             1             0
Arm/Group Title Active Quetiapine SR Quetiapine SR Placebo Total
Hide Arm/Group Description mood stabilizer plus active quetiapine sr mood stabilizer plus quetiapine SR placebo Total of all reporting groups
Overall Number of Baseline Participants 15 13 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 13 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
13
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 13 participants 28 participants
35.5  (10.1) 32.1  (9.8) 34  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 13 participants 28 participants
Female
8
  53.3%
11
  84.6%
19
  67.9%
Male
7
  46.7%
2
  15.4%
9
  32.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 13 participants 28 participants
15 13 28
1.Primary Outcome
Title Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.
Hide Description The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.
Time Frame Baseline visit to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Active Quetiapine S.R., 200-600mg, po, qd Placebo Quetiapine S.R. 200-600mg, po, qd
Hide Arm/Group Description:
Atypical antipsychotic quetiapine S.R. plus mood stabilizer
mood stabilizer plus quetiapine S.R. placebo
Overall Number of Participants Analyzed 15 13
Measure Type: Number
Unit of Measure: participants
MADRS 4 4
YMRS 4 4
Time Frame 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mood Stabilizer Plus Quetiapine SR Mood Stabilizer Plus Quetiapine sr Placebo
Hide Arm/Group Description mood stabilizer plus active quetiapine SR mood stabilizer plus quetiapine SR placebo
All-Cause Mortality
Mood Stabilizer Plus Quetiapine SR Mood Stabilizer Plus Quetiapine sr Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mood Stabilizer Plus Quetiapine SR Mood Stabilizer Plus Quetiapine sr Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mood Stabilizer Plus Quetiapine SR Mood Stabilizer Plus Quetiapine sr Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/15 (66.67%)      7/13 (53.85%)    
Gastrointestinal disorders     
nausea   2/15 (13.33%)  2 0/13 (0.00%)  0
General disorders     
dry mouth   4/15 (26.67%)  4 2/13 (15.38%)  2
joint pain   2/15 (13.33%)  2 0/13 (0.00%)  0
headache   1/15 (6.67%)  1 2/13 (15.38%)  2
Investigations     
drowsiness/sedation   7/15 (46.67%)  7 3/13 (23.08%)  3
interrupted sleep   2/15 (13.33%)  2 0/13 (0.00%)  0
Metabolism and nutrition disorders     
increased appetite   1/15 (6.67%)  1 2/13 (15.38%)  2
Musculoskeletal and connective tissue disorders     
muscle weakness   2/15 (13.33%)  2 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
Overall limitations were screen failures and lost to follow-ups which led to not reaching recruitment goals.
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: Charles L Bowden, MD
Organization: UTHSCSA
Phone: 210-567-5393
EMail: BowdenC@uthscsa.edu
Layout table for additonal information
Responsible Party: Charles L. Bowden, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01195363     History of Changes
Other Study ID Numbers: HSC20070253H
First Submitted: September 2, 2010
First Posted: September 6, 2010
Results First Submitted: April 3, 2013
Results First Posted: February 12, 2015
Last Update Posted: March 23, 2017