Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients

Sponsor
University of Regensburg (Other)
Overall Status
Completed
CT.gov ID
NCT00554658
Collaborator
AstraZeneca (Industry)
30
1
1
36
0.8

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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Quetiapine Induced Neuroplasticity in Schizophrenic Patients: A Combined Transcranial Magnetic Stimulation (TMS) and Voxel-based Morphometry (VBM) Study
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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:
  • Seroquel IR
  • Seroquel Prolong
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Change of functional neuroplasticity (i.e. cortical excitability) under quetiapine treatment assessed by paired-pulse TMS [3 weeks]

    2. To evaluate the influence of BDNF gene polymorphisms on clinical effects of quetiapine treatment, cortical excitability and brain morphology [3 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Goeran Hajak, Prof. Dr. med., University of Regensburg
    ClinicalTrials.gov Identifier:
    NCT00554658
    Other Study ID Numbers:
    • D1443L00015
    First Posted:
    Nov 7, 2007
    Last Update Posted:
    Oct 24, 2011
    Last Verified:
    Oct 1, 2011
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 24, 2011