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Trial record 84 of 455 for:    QUETIAPINE

Quetiapine Extended Release (XR) Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder (MDD/GAD)

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: NCT00868374
Recruitment Status : Terminated (Study terminated due to low enrollment)
First Posted : March 25, 2009
Results First Posted : February 11, 2014
Last Update Posted : December 29, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Keming Gao, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE March 24, 2009
First Posted Date  ICMJE March 25, 2009
Results First Submitted Date  ICMJE November 1, 2013
Results First Posted Date  ICMJE February 11, 2014
Last Update Posted Date December 29, 2016
Study Start Date  ICMJE June 2008
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17) [ Time Frame: Week 0 - Week 8 ]
The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25-52 indicates severe depression.
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2009)
Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17) [ Time Frame: Week 0 - Week 8 ]
Change History Complete list of historical versions of study NCT00868374 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 Extended Release (XR) Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder
Official Title  ICMJE Quetiapine XR Monotherapy or Adjunctive Therapy to Antidepressants in the Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder
Brief Summary The primary objective is to test the hypothesis that quetiapine XR (Extended Release) monotherapy or adjunctive therapy to antidepressant is superior to placebo monotherapy or placebo adjunctive therapy to antidepressant(s) in the acute treatment of depression symptoms in patients with MDD and comorbid GAD. The secondary objectives are to test the hypotheses that quetiapine XR is superior to placebo in the reduction of anxiety symptoms in patients with major depressive disorder and comorbid generalized anxiety disorder, the improvement of the quality of sleep in patients with major depressive disorder and comorbid generalized anxiety disorder and the improvement of the quality of life in patients with major depressive disorder and comorbid generalized anxiety disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: Quetiapine XR
    Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
    Other Name: Seroquel
  • Drug: Placebo
    Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
Study Arms  ICMJE
  • Experimental: 1
    Quetiapine XR
    Intervention: Drug: Quetiapine XR
  • Placebo Comparator: 2
    Intervention: Drug: 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 Terminated
Actual Enrollment  ICMJE
 (submitted: December 23, 2013)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2009)
100
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to provide informed consent before beginning any study-specific procedures
  • Male and female patients at least 18 years of age - 70 years of age
  • Meets Diagnostic and Statistical Manual IV (DSM-IV) criteria for MDD, currently depressed
  • DSM-IV diagnosis of current GAD
  • Women with reproductive potential must have a negative urine pregnancy test

Exclusion Criteria:

  • Patients who have had a current episode of depression for less than 4 weeks from enrollment
  • Patients who have been treated for their current depressive episode for more than 3 weeks with Quetiapine therapy 50 mg/day
  • Patients currently taking antidepressants known to cause somnolence/sedation such as mirtazapine or unable to wean off current antidepressant if they choose monotherapy
  • Patients who meet DSM-IV criteria for substance dependence confirmed by the Substance Use Disorder Module of the Structured Clinical Interview for DSM-IV (SCID), for any substance except for caffeine and nicotine, with substance abuse within last 3 months or substance dependence within last 6 months;
  • Concurrent obsessive-compulsive disorder
  • Patients with a history of clinically significant cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease, or other disease or clinical finding that is unstable or that, in the opinion of the investigator, would be negatively effected by trial medication or that would effect trial medication
  • A patient with diabetes mellitus (DM) fulfilling one of the following criteria:

    • Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) > 8.5%
    • Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks
    • Not under physician care for DM
    • Physician responsible for patient's DM care has not indicated that the patient's DM is controlled
    • Physician responsible for patient's DM care has not approved the patient's participation in the study
    • Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization (for thiazolidinediones (glitazones) this period should not be less than 8 weeks before randomization)
    • Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks

Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study. A patient could be enrolled at a later time if DM is stabilized.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 NCT00868374
Other Study ID Numbers  ICMJE 12-07-29
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Keming Gao, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE Keming Gao
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Keming Gao, MD, PhD University Hospitals Cleveland Medical Center
PRS Account University Hospitals Cleveland Medical Center
Verification Date November 2016

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