Phase
Condition
Anxiety Disorders
Panic Disorders
Mood Disorders
Treatment
N/AClinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 laboratoryscreening, the patient is, in the investigator's opinion, in suitable condition.
Exclusion
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 ora danger to self or others
Known intolerance or lack of response to quetiapine fumarate, as judged by theinvestigator
Use of any of the following P450 3A4 inhibitors in the 14 days preceding enrollmentincluding but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin,clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, andsaquinavir.
Use of any of the following cytochrome P450 inducers in the 14 days precedingenrolment 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 thedepot) before randomization
Substance or alcohol dependence at enrolment (except dependence in full remission, andexcept for caffeine or nicotine dependence), as defined by the DSM-IV criteria
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IVcriteria within 4 weeks prior to enrolment
Positive drug screen result at screening visit and if clinically relevant judged bythe investigator
Medical conditions that would affect absorption, distribution, metabolism, orexcretion 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 orlonger 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. Thosewho 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 potentiallyanxiolytic or with psychobiological activity, will have terminated usage of the agentmore 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 throughclinical interpretation to be significant
Serious illness: Liver or renal insufficiency, cardiac, vascular, pulmonary,gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolicdisturbance
An absolute neutrophil count (ANC) of <1.5 x 109 per liter.
Unstable Diabetes Mellitus/HbA1c
Study Design
Connect with a study center
START Clinic for the Mood and Anxiety Disorders
Toronto, Ontario M4W 2N4
CanadaSite Not Available
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