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

NCT00868374 | Terminated Phase 3 Results DMC

• 1 other identifier: 12-07-29
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)

  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.

  Week 0 - Week 8

Study Arms (2)

1

EXPERIMENTAL

Quetiapine XR

Drug: Quetiapine XR

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Quetiapine XR DRUG

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

Also known as: Seroquel

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Keming Gao: lead
• AstraZeneca: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Keming Gao
• Organization: University Hospitals Cleveland Medical Center

keming.gao@UHhospitals.org

216-844-2865

Study Officials

• Keming Gao, MD, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Mood and Anxiety Clinic

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: June 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 29, 2016
• Results First Posted: February 11, 2014

Record last verified: 2016-11

Locations

US (1)