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

Last updated: November 9, 2016
Sponsor: Keming Gao
Overall Status: Terminated

Phase

3

Condition

Mood Disorders

Panic Disorders

Affective Disorders

Treatment

N/A

Clinical Study ID

NCT00868374
12-07-29
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, currentlydepressed

  • DSM-IV diagnosis of current GAD

  • Women with reproductive potential must have a negative urine pregnancy test

Exclusion

Exclusion Criteria:

  • Patients who have had a current episode of depression for less than 4 weeks fromenrollment

  • Patients who have been treated for their current depressive episode for more than 3weeks with Quetiapine therapy 50 mg/day

  • Patients currently taking antidepressants known to cause somnolence/sedation such asmirtazapine or unable to wean off current antidepressant if they choose monotherapy

  • Patients who meet DSM-IV criteria for substance dependence confirmed by the SubstanceUse Disorder Module of the Structured Clinical Interview for DSM-IV (SCID), for anysubstance except for caffeine and nicotine, with substance abuse within last 3 monthsor 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 findingthat is unstable or that, in the opinion of the investigator, would be negativelyeffected 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 12weeks

  • Not under physician care for DM

  • Physician responsible for patient's DM care has not indicated that the patient'sDM is controlled

  • Physician responsible for patient's DM care has not approved the patient'sparticipation in the study

  • Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4weeks before randomization (for thiazolidinediones (glitazones) this periodshould not be less than 8 weeks before randomization)

  • Taking insulin whose daily dose on one occasion in the past 4 weeks has been morethan 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 evenif the treating physician believes that the patient is stable and can participate in thestudy. A patient could be enrolled at a later time if DM is stabilized.

Study Design

Total Participants: 23
Study Start date:
June 01, 2008
Estimated Completion Date:
October 31, 2011

Connect with a study center

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

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