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Trial record 40 of 455 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

Tracking Information
First Submitted Date  ICMJE September 2, 2010
First Posted Date  ICMJE September 6, 2010
Results First Submitted Date  ICMJE April 3, 2013
Results First Posted Date  ICMJE February 12, 2015
Last Update Posted Date March 23, 2017
Study Start Date  ICMJE April 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2015)
Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores. [ Time Frame: Baseline visit to week 24 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2010)
assess efficacy of quetiapine SR adjunct to mood stabilizer in mixed states [ Time Frame: 6mos ]
Change History Complete list of historical versions of study NCT01195363 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder
Brief Summary To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: quetiapine SR
    quetiapine SR, dose range 200-600mg, each night QHS for 6mos
    Other Name: Seroquel SR
  • Drug: quetiapine sr placebo
    quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos
Study Arms  ICMJE
  • Active Comparator: quetiapine SR
    quetiapine SR, 200-600mg, po, qd
    Intervention: Drug: quetiapine SR
  • Placebo Comparator: quetiapine sr Placebo
    quetiapine SR placebo, 200-600mg, po qd
    Intervention: Drug: quetiapine sr placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2015)
28
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2010)
66
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female;
  • Age 18 years and older
  • Patients on:

    • Li at a stable dose for 4 weeks or longer, and a serum level at screening of 0.5 mEq/l OR
    • DIV dose for 4 weeks or longer, and a serum level at screening of 45 g/ml OR
    • LAM (dosage/day ≥100mg) at a stable dose for 4 weeks or longer OR
    • Any combination 3a, 3b, or 3c
  • Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7
  • Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score>/=14
  • Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 ;
  • Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14

Exclusion Criteria:

  • Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic subtype, drug induced mania or AIDS induced mania
  • Women with a positive pregnancy test or who are lactating
  • Women of child-bearing potential who are not practicing a clinically accepted method of contraception
  • Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
  • Patients whose clinical status requires inpatient or day hospital treatment
  • History of severe side effects associated with therapeutic doses of Li, DIV, LAM
  • Alcohol or drug dependent at time of enrollment
  • Suicidal at time of enrollment.
  • Current or previous exposure to QTP
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01195363
Other Study ID Numbers  ICMJE HSC20070253H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles L. Bowden, The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Charles Bowden, MD University of Texas
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP