Quetiapine Induced Neuroplasticity in First-Episode Schizophrenic Patients - Full Text View

Sponsors and Collaborators:	University of Regensburg AstraZeneca
Information provided by:	University of Regensburg
ClinicalTrials.gov Identifier:	NCT00554658

Purpose

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	Intervention	Phase
Schizophrenia	Drug: Quetiapine	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment
Official Title:	Quetiapine Induced Neuroplasticity in Schizophrenic Patients: A Combined Transcranial Magnetic Stimulation (TMS) and Voxel-Based Morphometry (VBM) Study

Further study details as provided by University of Regensburg:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	March 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554658

Contacts

Contact: Goeran Hajak, MD, PhD	49-941-941-2010	goeran.hajak@medbo.de
Contact: Peter Eichhammer, MD	49-941-941-2056	peter.eichhammer@medbo.de

Locations

Germany
University of Regensburg, Department of Psychiatry	Recruiting
Regensburg, Germany, 93053
Principal Investigator: Goeran Hajak, MD,PhD
Sub-Investigator: Peter Eichhammer, MD
Sub-Investigator: Berthold Langguth, MD
Sub-Investigator: Michael Landgrebe, MD

Sponsors and Collaborators

University of Regensburg

AstraZeneca

Investigators

Principal Investigator:

Goeran Hajak, MD, PhD

University of Regensburg

More Information

Responsible Party:	Medical Institutions of the District Oberpflaz/Bayern/Germany (MedBO GmbH) ( Kurt Häupl )
Study ID Numbers:	D1443L00015
Study First Received:	November 6, 2007
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00554658
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009