SE OF CLINICAL AND INTERMEDIATE PHENOTYPES TO ASSESS RESPONSE TO QUETIAPINE: THE ROLE OF PUTATIVE CAUSATIVE GENES - ND

• Conditions: schizophrenia using the Structured Clinical Interview for Diagnosis (SCID) for the Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV); MedDRA version: 9.1Level: SOCClassification code 10037175

• Registration Number: EUCTR2009-013028-21-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-10
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

2. Diagnosis of schizophrenia using the Structured Clinical Interview for Diagnosis (SCID) for the Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV); 3. Male or female patients aged between 18 and 65 years; 4. 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; 5. Able to understand and comply with the requirements of the study. 6. Patients with a cut off value for PANSS more than 75.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnancy or lactation; 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria; 3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others; 4. Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator; 5. 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;6. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids; 7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization; 8. Patients treated with clozapine within 28 days before the enrolment; 9. Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria; 10. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment; 11. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment; 12. Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator; 13. Involvement in the planning and conduct of the study; 14. Previous enrollment or randomization of treatment in the present study; 15. Participation in another drug trial within 4 weeks prior to enrollment into this study or longer in accordance with local requirements; 16. A patient with Diabetes Mellitus (DM)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary measure of efficacy will be the change from baseline in clinical symptoms assessed by PANSS scores measures based on BDNF genotype in schizophrenic patients after quetiapine XR treatment.;Main Objective: The objective of the present study is to identify possible predictors of clinical response to treatment with quetiapine XR in patients with schizophrenia;Secondary Objective: The secondary objective is to evaluate the improvements in cognitive symptoms (working memory, episodic memory and attention) as well as patterns of cortical activation during working memory and episodic memory after quetiapine XR treatment.