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
Conditions
Interventions
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
Sponsors
Medical Institutions of the District Oberpfalz/Bayern (MedBO GmbH)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: - Neuroleptic treatment prior to study enrolment - Pregnancy or lactation - Any DSM-IV Axis I disorder not defined in the inclusion criteria - Known intolerance or lack of response to quetiapine fumarate as judged by the investigator - Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria - Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment - Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment - History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery - Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator - Concomitant treatment with psychotropic drugs (e.g. antidepressive agents, anticonvulsants, other neuroleptics) except benzodiazepines or hypnotics - Cardiac pace makers, other electronic implants, intracranial metallic particles - History of seizures or epileptiform activity - An absolute neutrophil count (ANC) of £1.5 x 109 per liter. - Unstable Diabetes mellitus/HbA1c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;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). ;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 | — |
Countries
Germany
Outcome results
None listed