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

NCT ID: NCT00868374

Last Updated: 2016-12-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2011-10-31

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.

Conditions

Major Depressive Disorder; Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Quetiapine XR

Group Type: EXPERIMENTAL

Quetiapine XR

Intervention Type: DRUG

Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day

Interventions

Quetiapine XR

Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day

Intervention Type: DRUG

Placebo

Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day

Intervention Type: DRUG

Other Intervention Names

Seroquel

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Keming Gao

OTHER

Sponsor Role: lead

Responsible Party

Keming Gao

Director, Mood and Anxiety Clinic

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Keming Gao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

12-07-29

Identifier Type: -

Identifier Source: org_study_id