Flushing in Social Anxiety Disorder on Seroquel

This is an interventional treatment trial for Social Anxiety Disorder Read More

Inclusion Criteria:

• The patient has provided signed informed consent prior to any study-related procedures
• Outpatient male or female aged 18-65 (inclusive).
• Patients with a primary diagnosis of Social Phobia to DSM IV (300.23) criteria (diagnosis to be made using the MINI International Neuropsychiatric Interview (MINI).
• Score of > 60 on the LSAS.
• On the basis of a physical examination, medical history and basic laboratory screening, the patient is, in the investigator's opinion, in suitable condition.

Exclusion Criteria:

• Pregnancy or lactation
• Any DSM-IV Axis I disorder not defined in the inclusion criteria
• Patients who, in the opinion of the investigator, pose an immediate 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 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 inducers in the 14 days preceding enrolment 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 enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by the DSM-IV criteria
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
• Positive drug screen result at screening visit and if clinically relevant judged by the investigator
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
• Unstable or inadequately treated medical illnesses (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
• Involvement in the planning or conduct of the study
• Previous enrollment or randomization of treatment in the present study
• Participation in another drug trail within 4 weeks prior enrollment into this study or longer in accordance with local requirements
• Continuation or commencement of formal psychotherapy
• Current use of or commencement of antidepressant and anxiolytic medications
• Patients, who have been on an antidepressant or other anxiolytic prior to the study, will have discontinues these more than two weeks prior to entry into the study. Those who have been on fluoxetine, will have been off for at least five weeks.
• Patients, who have been on a herbal or alternative treatment judged to be potentially anxiolytic or with psychobiological activity, will have terminated usage of the agent more than two weeks prior to entering the study
• Previous reactions to Niacin administration
• Use of a non-steroidal anti-inflammatory
• Any psychotic disorder
• Eating disorder as defined in the DSM IV
• Mental retardation or other cognitive disorder
• Laboratory values at screening or in medical history that may be considered through clinical interpretation to be significant
• Serious illness: Liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance
• An absolute neutrophil count (ANC) of <1.5 x 109 per liter.
• Unstable Diabetes Mellitus/HbA1c