Generalized Anxiety Disorder, Major Depressive Disorder
Conditions
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.
Interventions
DRUGQuetiapine XR
Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
DRUGPlacebo
Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
Sponsors
AstraZeneca
Keming Gao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Quetiapine XR Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day | 12 |
| Placebo Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day | 11 |
| Total | 23 |
Baseline characteristics
| Characteristic | Quetiapine XR | Total | Placebo |
|---|---|---|---|
| Age, Continuous Age | 48.3 years STANDARD_DEVIATION 11.3 | 45.1 years STANDARD_DEVIATION 7.1 | 41.2 years STANDARD_DEVIATION 6.1 |
| Gender Female | 9 Participants | 18 Participants | 9 Participants |
| Gender Male | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 11 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 12 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 12 | 8 / 11 |
| serious Total, serious adverse events | 0 / 12 | 1 / 11 |
Outcome results
Primary
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.
Time frame: Week 0 - Week 8
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine XR | Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17) | -0.5 units on a scale |
| Placebo | Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17) | 3.9 units on a scale |