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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder, Generalized Anxiety Disorder

In brief

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.

Key facts

Study ID: NCT00868374
Run by: Keming Gao
People needed: 23
Starts: 2008-06-01
Expected to finish: 2011-10-01
Last updated by the study team: 2016-12-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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