Quetiapine induced neuroplasticity in schizophrenic patients: A combined TMS and VBM study

INTERVENTION: Trade Name: Seroquel 25mg Filmtabletten Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: QUETIAPINE CAS Number: 111974697 Current Sponsor code: D1443L00015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25mg‐800mg Trade Name: Seroquel 100 mg Filmtabletten Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: QUETIAPINE CAS Number: 111974697 Current Sponsor code: D1443L00015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25mg‐800mg Trade Name: Seroquel 200 mg Filmtabletten Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: QUETIAPINE CAS Number: 111974697 Current Sponsor code: D1443L00015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25mg‐800mg Trade Name: Seroquel 300 mg Filmtabletten Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: QUETIAPINE CAS Number: 111974697 Current Sponsor code: D1443L00015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25mg‐800mg CONDITION: Neuroleptika‐naive patients with a first episode of schizophrenia according to DSM‐IV criteria. ; MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia PRIMARY OUTCOME: Main Objective: To evaluate the effect of treatment with quetiapine on aspects of structural neuroplasticity assessed by means of Voxel‐based morphometry (changes in gray matter density baseline versus steady‐state treatment). Primary end point(s): The primary endpoint will be a significant change of gray matter densitiy under treatment with quetiapine assessed by voxel‐based morphometry Secondary Objective: ‐ To evaluate the effect of treatment with quetiapine on aspects of functional neuroplasticity assessed by paired‐pulse TMS (baseline versus steady‐state).; ; ‐ To compare clinical effects of treatment with quetiapine (i.e. changes in symptomatology) with changes in aspects of functional and structural neuroplasticity.; ; ‐ To evaluate the influence of BDNF gene polymorphisms on clinical effects of quetiapine treatment, cortical excitability and brain morphology (baseline versus steady‐state).; INCLUSION CRITERIA: ‐ Provision of written informed consent ‐ A diagnosis of first episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders‐ Fourth Edition (DSM‐IV) criteria and no history of neuroleptic medication ‐ Females and/or males aged 18 to 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 enrolment ‐ Able to understand and comply with the requirements of the study ‐ Mild to moderate schizophrenia 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