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

• ClinicalTrials.gov Identifier: NCT00868374
• Recruitment Status: Terminated
• First Posted: March 25, 2009
• Results First Posted: February 11, 2014
• Last Update Posted: December 29, 2016
• Sponsor: Keming Gao
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): Keming Gao, University Hospitals Cleveland Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder; Generalized Anxiety Disorder	Drug: Quetiapine XR; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: June 2008
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: October 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17) [ Time Frame: Week 0 - Week 8 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Ohio

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

Keming Gao

AstraZeneca

Investigators

• Principal Investigator: Keming Gao, MD, PhD; University Hospitals Cleveland Medical Center

More Information

• Responsible Party: Keming Gao, Director, Mood and Anxiety Clinic, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT00868374
• Other Study ID Numbers: 12-07-29
• First Posted: March 25, 2009
• Results First Posted: February 11, 2014
• Last Update Posted: December 29, 2016
• Last Verified: November 2016

Additional relevant MeSH terms:

Disease; Anxiety Disorders; Depressive Disorder; Depression; Depressive Disorder, Major; Pathologic Processes; Mental Disorders; Mood Disorders; Behavioral Symptoms; Quetiapine Fumarate; Antidepressive Agents; Psychotropic Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs