Quetiapine induced neuroplasticity in schizophrenic patients: A combined TMS and VBM study
- Conditions
- euroleptika-naive patients with a first episode of schizophrenia according to DSM-IV criteria.MedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia
- Registration Number
- EUCTR2007-000545-35-DE
- Lead Sponsor
- Medical Institutions of the District Oberpfalz/Bayern (MedBO GmbH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method