Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients
Study Details
Study Description
Brief Summary
Aim of the study is to assess the effect of quetiapine treatment in neuroleptic naive, first-episode schizophrenic patients on aspects of functional and structural neuroplasticity assessed by means of transcranial magnetic stimulation and voxel-based morphometry. Main outcome measure is a change in gray matter density under quetiapine treatment from baseline to steady-state-treatment after 3 weeks.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: A Patients will be taken quetiapine for the treatment of first episode schizophrenia. |
Drug: Quetiapine
Quetiapine will be administered open label as clinically required according to current guidelines. Target dose range: 400 - 800 mg quetiapine per day.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change of structural neuroplasticity (i.e. change in gray matter density) under treatment with quetiapine assessed by voxel-based morphometry. [3 weeks]
Secondary Outcome Measures
- Change of functional neuroplasticity (i.e. cortical excitability) under quetiapine treatment assessed by paired-pulse TMS [3 weeks]
- To evaluate the influence of BDNF gene polymorphisms on clinical effects of quetiapine treatment, cortical excitability and brain morphology [3 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Females and/or males aged 18 to 65 years
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Mild to moderate schizophrenia
Exclusion Criteria:
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Neuroleptic treatment prior to study enrollment
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Pregnancy or lactation
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Any DSM-IV Axis I disorder not defined in the inclusion criteria
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Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
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Known intolerance or lack of response to quetiapine fumarate as judged by the investigator
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Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
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Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
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Any history of neuroleptic treatment
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Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
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Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
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Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
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Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator
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Involvement in the planning and conduct of the study
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History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery
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Concomitant treatment with psychotropic drugs (e.g. antidepressive agents, anticonvulsants, other neuroleptics) except benzodiazepines or hypnotics
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Regensburg, Department of Psychiatry | Regensburg | Germany | 93053 |
Sponsors and Collaborators
- University of Regensburg
- AstraZeneca
Investigators
- Principal Investigator: Goeran Hajak, MD, PhD, University of Regensburg
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1443L00015