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Trial record 57 of 450 for:    QUETIAPINE

Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes

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ClinicalTrials.gov Identifier: NCT00397020
Recruitment Status : Completed
First Posted : November 8, 2006
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
David Feifel, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: divalproex ER
Drug: quetiapine
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1 Divalproex ER 2 Quetiapine Fumarate
Hide Arm/Group Description Divalproex ER quetiapine fumarate
Period Title: Overall Study
Started 14 16
Completed 13 15
Not Completed 1 1
Arm/Group Title 1 Divalproex ER 2 Quetiapine Fumarate Total
Hide Arm/Group Description Divalproex ER quetiapine fumarate Total of all reporting groups
Overall Number of Baseline Participants 13 15 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
15
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 15 participants 28 participants
42.4
(19 to 64)
36.9
(19 to 64)
39.65
(19 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Female
5
  38.5%
7
  46.7%
12
  42.9%
Male
8
  61.5%
8
  53.3%
16
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 15 participants 28 participants
13 15 28
1.Primary Outcome
Title Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7
Hide Description Minimum: 0 Maximum: 60 Higher scores indicate worse outcome
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Divalproex ER 2 Quetiapine Fumarate
Hide Arm/Group Description:
Divalproex ER
quetiapine fumarate
Overall Number of Participants Analyzed 10 15
Mean (Standard Error)
Unit of Measure: units on a scale
14.8  (2.1) 13.9  (1.9)
2.Secondary Outcome
Title Young Mania Rating Scale (YMRS) Secondary Endpoints
Hide Description [Not Specified]
Time Frame weekly - Day 3, 14, 21
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Clinical Global Impression: Severity (CGI:S)
Hide Description [Not Specified]
Time Frame each visit
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Clinical Global Impression: Improvement (CGI:I)
Hide Description [Not Specified]
Time Frame each week/visit
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Readiness to Discharge Questionnaire (RDQ)
Hide Description [Not Specified]
Time Frame each week/visit in the hospital
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description [Not Specified]
Time Frame each week/visit
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Behavioral Activity Rating Scale (BARS)
Hide Description [Not Specified]
Time Frame each week/visit
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Extrapyramidal Symptoms Rating Scale (ESRS)
Hide Description [Not Specified]
Time Frame each week/visit
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 Divalproex ER 2 Quetiapine Fumarate
Hide Arm/Group Description Divalproex ER quetiapine fumarate
All-Cause Mortality
1 Divalproex ER 2 Quetiapine Fumarate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1 Divalproex ER 2 Quetiapine Fumarate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 Divalproex ER 2 Quetiapine Fumarate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      5/15 (33.33%)    
Nervous system disorders     
Neurological (fainting, dizziness, headaches)  1/13 (7.69%)  1 5/15 (33.33%)  5
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. David Feifel
Organization: UCSD Medical Center
Phone: 619-543-2485
EMail: dfeifel@ucsd.edu
Layout table for additonal information
Responsible Party: David Feifel, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00397020     History of Changes
Other Study ID Numbers: Bipolar Mania
First Submitted: November 6, 2006
First Posted: November 8, 2006
Results First Submitted: December 19, 2016
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019