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

This study has been terminated.
(Study terminated due to low enrollment)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr. Keming Gao, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00868374
First received: March 24, 2009
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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
Major Depressive Disorder
Generalized Anxiety Disorder
Drug: Quetiapine XR
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quetiapine XR Monotherapy or Adjunctive Therapy to Antidepressants in the Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17) [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 23
Study Start Date: June 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Quetiapine XR
Drug: Quetiapine XR
Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
Other Name: Seroquel
Placebo Comparator: 2 Drug: Placebo
Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868374

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Dr. Keming Gao
AstraZeneca
Investigators
Principal Investigator: Keming Gao, MD, PhD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Dr. Keming Gao, Director, Mood and Anxiety Clinic, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT00868374     History of Changes
Other Study ID Numbers: 12-07-29
Study First Received: March 24, 2009
Results First Received: November 1, 2013
Last Updated: December 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Depressive Disorder
Depression
Depressive Disorder, Major
Mental Disorders
Mood Disorders
Behavioral Symptoms
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 20, 2014