quetiapine augmentation for primary anxiety disorder or mood disorders with co-morbid anxiety symptoms

Conditions: Primary Anxiety Disorders; Mood Disorders With Comorbid Anxiety Symptoms

Summary: the objectives of this study are to evaluate the efficacy and safety of quetiapine extended release tablet versus placebo as adjunct to selective serotonin reuptake inhibitors/serotonin/norepinephrine reuptake inhibitors (ssri/snri) in the augmentation treatment of patient with primary anxiety disorders or mood disorders with co-morbid anxiety symptoms.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * a diagnosis of primary anxiety disorder or mood disorder with co-morbid anxiety symptoms by diagnostic and statistical manual of mental disorders-fourth edition (dsm-iv) * a 14-item hamilton anxiety scale (ham-a)\>= 14 * subject have received single antidepressant at a therapeutic dose for at least 6 weeks * male or female aged 18-65 years * female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (hcg) test at enrollment * able to understand and comply with the requirements of the study and sign informed consent exclusion criteria: * pregnancy or lactation * any dsm-iv axis i disorder not defined in the inclusion criteria. * receiving any anti-psychotic 7 days prior to entering the study * patients who, in the opinion of the investigator, post an imminent risk of suicide or a danger to self or others * known intolerance or lack of response to quetiapine fumarate, as judged by the investigator * use of any of the following cytochrome p450 3a4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir * use of any of the following cytochrome p450 3a4 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, st.john's wort, and glucocorticoids * administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization * substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by dsm-iv criteria * opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by dsm-iv criteria within 4 weeks prior to enrollment * medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment * unstable or inadequately treated medical illness (e.g. congestive heart failures, angina pectoris, hypertension) as judged by the investigator * involvement in the planning and conduct of the study * previous enrollment or randomization of treatment in the present study * participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements * 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 in past 12 weeks. * not under physician care for dm * physician responsible for patient's dm care has not indicated that patient's dm is controlled * physician responsible for patient's dm care has not approved patient's participation in the study * has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. for thiazolidinediones(glitazones) this period should not be less than 8 weeks * 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 * an absolute neutrophil count (anc) of \<= 1.5x10(9) per liter

Keywords: primary anxiety disorders mood disorders with comorbid anxiety symptoms