Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Goeran Hajak, University of Regensburg
ClinicalTrials.gov Identifier:
NCT00554658
First received: November 6, 2007
Last updated: October 21, 2011
Last verified: October 2011

November 6, 2007
October 21, 2011
March 2008
December 2010   (final data collection date for primary outcome measure)
Change of structural neuroplasticity (i.e. change in gray matter density) under treatment with quetiapine assessed by voxel-based morphometry. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Change of structural neuroplasticity (i.e. change in gray matter density) under treatment with quetiapine assessed by voxel-based morphometry. [ Time Frame: 3 weeks ]
Complete list of historical versions of study NCT00554658 on ClinicalTrials.gov Archive Site
  • Change of functional neuroplasticity (i.e. cortical excitability) under quetiapine treatment assessed by paired-pulse TMS [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • To evaluate the influence of BDNF gene polymorphisms on clinical effects of quetiapine treatment, cortical excitability and brain morphology [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients
Quetiapine Induced Neuroplasticity in Schizophrenic Patients: A Combined Transcranial Magnetic Stimulation (TMS) and Voxel-based Morphometry (VBM) Study

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
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:
  • Seroquel IR
  • Seroquel Prolong
Active Comparator: A
Patients will be taken quetiapine for the treatment of first episode schizophrenia.
Intervention: Drug: Quetiapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00554658
D1443L00015
No
Goeran Hajak, University of Regensburg
University of Regensburg
AstraZeneca
Principal Investigator: Goeran Hajak, MD, PhD University of Regensburg
University of Regensburg
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP