Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients

Overview

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.

Full Title of Study: “Quetiapine Induced Neuroplasticity in Schizophrenic Patients: A Combined Transcranial Magnetic Stimulation (TMS) and Voxel-based Morphometry (VBM) Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

Interventions

  • Drug: Quetiapine
    • Quetiapine will be administered open label as clinically required according to current guidelines. Target dose range: 400 – 800 mg quetiapine per day.

Arms, Groups and Cohorts

  • Active Comparator: A
    • Patients will be taken quetiapine for the treatment of first episode schizophrenia.

Clinical Trial Outcome Measures

Primary Measures

  • Change of structural neuroplasticity (i.e. change in gray matter density) under treatment with quetiapine assessed by voxel-based morphometry.
    • Time Frame: 3 weeks

Secondary Measures

  • Change of functional neuroplasticity (i.e. cortical excitability) under quetiapine treatment assessed by paired-pulse TMS
    • Time Frame: 3 weeks
  • To evaluate the influence of BDNF gene polymorphisms on clinical effects of quetiapine treatment, cortical excitability and brain morphology
    • Time Frame: 3 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • 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 – Mild to moderate schizophrenia Exclusion Criteria:

  • Neuroleptic treatment prior to study enrollment – Pregnancy or lactation – Any DSM-IV Axis I disorder not defined in the inclusion criteria – Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others – Known intolerance or lack of response to quetiapine fumarate as judged by the investigator – 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 – 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 – Any history of neuroleptic treatment – Substance or alcohol dependence at enrollment (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 enrollment – Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment – Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator – Involvement in the planning and conduct of the study – History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery – Concomitant treatment with psychotropic drugs (e.g. antidepressive agents, anticonvulsants, other neuroleptics) except benzodiazepines or hypnotics

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Regensburg
  • Collaborator
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Principal Investigator: Goeran Hajak, Prof. Dr. med. – University of Regensburg
  • Overall Official(s)
    • Goeran Hajak, MD, PhD, Principal Investigator, University of Regensburg

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