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Sponsors and Collaborators: |
University Hospital Case Medical Center AstraZeneca |
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Information provided by: | University Hospital Case Medical Center |
ClinicalTrials.gov Identifier: | NCT00868374 |
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.
Condition | Intervention | Phase |
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Major Depressive Disorder Generalized Anxiety Disorder |
Drug: Quetiapine XR Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Quetiapine XR Monotherapy or Adjunctive Therapy to Antidepressants in the Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Quetiapine XR
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Drug: Quetiapine XR
Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
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2: Placebo Comparator |
Drug: Placebo
Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A patient with diabetes mellitus (DM) fulfilling one of the following criteria:
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.
Contact: Elizabeth Fein, MA | 216-844-2863 | elizabeth.fein@UHhospitals.org |
United States, Ohio | |
University Hospitals Case Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Liz Fein, MA 216-844-2863 elizabeth.fein@UHhospitals.org | |
Principal Investigator: Keming Gao, MD, PhD |
Principal Investigator: | Keming Gao, MD, PhD | University Hospitals Case Medical Center |
Responsible Party: | University Hospital Case Medical Center ( Keming Gao, MD, PhD ) |
Study ID Numbers: | 12-07-29 |
Study First Received: | March 24, 2009 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00868374 History of Changes |
Health Authority: | United States: Institutional Review Board |
Depression Tranquilizing Agents Psychotropic Drugs Central Nervous System Depressants Depressive Disorder, Major Depressive Disorder Antipsychotic Agents |
Behavioral Symptoms Quetiapine Anxiety Disorders Mental Disorders Mood Disorders Antidepressive Agents |
Depression Disease Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Depressive Disorder, Major Depressive Disorder Antipsychotic Agents |
Pharmacologic Actions Behavioral Symptoms Quetiapine Pathologic Processes Anxiety Disorders Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents |