Phase
Condition
Mood Disorders
Panic Disorders
Affective Disorders
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, currentlydepressed
DSM-IV diagnosis of current GAD
Women with reproductive potential must have a negative urine pregnancy test
Exclusion
Exclusion Criteria:
Patients who have had a current episode of depression for less than 4 weeks fromenrollment
Patients who have been treated for their current depressive episode for more than 3weeks with Quetiapine therapy 50 mg/day
Patients currently taking antidepressants known to cause somnolence/sedation such asmirtazapine or unable to wean off current antidepressant if they choose monotherapy
Patients who meet DSM-IV criteria for substance dependence confirmed by the SubstanceUse Disorder Module of the Structured Clinical Interview for DSM-IV (SCID), for anysubstance except for caffeine and nicotine, with substance abuse within last 3 monthsor 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 findingthat is unstable or that, in the opinion of the investigator, would be negativelyeffected 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 12weeks
Not under physician care for DM
Physician responsible for patient's DM care has not indicated that the patient'sDM is controlled
Physician responsible for patient's DM care has not approved the patient'sparticipation in the study
Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4weeks before randomization (for thiazolidinediones (glitazones) this periodshould not be less than 8 weeks before randomization)
Taking insulin whose daily dose on one occasion in the past 4 weeks has been morethan 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 evenif the treating physician believes that the patient is stable and can participate in thestudy. A patient could be enrolled at a later time if DM is stabilized.
Study Design
Connect with a study center
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
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