Phase
Condition
Anxiety Disorders
Tourette's Syndrome
Panic Disorders
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of written informed consent;
A diagnosis of schizophrenia or schizophrenia spectrum psychosis (schizophreniform,schizoaffective, delusional disorder, brief psychosis) as defined by Diagnostic andStatistical Manual of Mental Disorders- Fourth Edition (DSM-IV);
Presenting a co-morbid anxiety disorder not well controlled with the currentpharmacological treatment according to the investigator corresponding to DSM-IV;
Having an initial score of more than 20 at enrolment on HAM-A scale;
Female patients of childbearing potential must be using a reliable method ofcontraception and have a negative urine human chorionic gonadotropin (HCG) test atenrolment;
Exclusion
Exclusion Criteria:
Patient with an antidepressant or benzodiazepine recently (last 4 weeks) introduced,or that had requested a dosing adjustment in the last 4 weeks;
Patient with an anticholinergic taken on a regular basis;
Patient receiving more than one antipsychotic;
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 imminent 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 cytochrome P450 3A4 inhibitors in the 14 days precedingenrolment 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 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 enrolment;
Substance or alcohol dependence at enrolment (except dependence in full remission, andexcept for caffeine or nicotine dependence), as defined by DSM-IV criteria;
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IVcriteria within 4 weeks prior to enrolment;
Medical conditions that would affect absorption, distribution, metabolism, orexcretion of study treatment;
Unstable or inadequately treated medical illness (e.g. congestive heart failure,angina pectoris, hypertension) as judged by the investigator;
Involvement in the planning and conduct of the study;
Previous enrolment of treatment in the present study;
Participation in a phase I-II-III drug trial within 4 weeks prior enrolment into thisstudy or longer in accordance with local requirements;
A patient with Diabetes Mellitus (DM) - An absolute neutrophil count (ANC) of 1.5 x 109 per liter;
An ALT-AST count of 3 x ULN and/or Bilirubin count 1.5 x ULN;
Any clinically significant laboratory abnormality, as judged by the investigator.
Study Design
Study Description
Connect with a study center
CRNPQ
Quebec, G1R2W8
CanadaSite Not Available
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