Quetiapine Induced Neuroplasticity in First-Episode Schizophrenic Patients

Condition(s) targeted: Schizophrenia

Intervention: Quetiapine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Regensburg

Official(s) and/or principal investigator(s):
Goeran Hajak, MD, PhD, Principal Investigator, Affiliation: University of Regensburg

Overall contact:
Goeran Hajak, MD, PhD, Phone: 49-941-941-2010, Email: goeran.hajak@medbo.de

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.

Official title: Quetiapine Induced Neuroplasticity in Schizophrenic Patients: A Combined Transcranial Magnetic Stimulation (TMS) and Voxel-Based Morphometry (VBM) Study

Study design: Other, Open Label, Uncontrolled, Single Group Assignment

Primary outcome: Change of structural neuroplasticity (i.e. change in gray matter density) under treatment with quetiapine assessed by voxel-based morphometry.

Secondary outcome:

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

To evaluate the influence of BDNF gene polymorphisms on clinical effects of quetiapine treatment, cortical excitability and brain morphology

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Goeran Hajak, MD, PhD, Phone: 49-941-941-2010, Email: goeran.hajak@medbo.de

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

Starting date: March 2008
Ending date: April 2010
Last updated: April 22, 2008