Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Quetiapine

• Registration Number: NCT00554658
• Lead Sponsor: University of Regensburg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-06
• Study First Posted: 2007-11-07
• Study Start: 2008-03
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-21
• Last Update Posted: 2011-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Quetiapine	Patients will be taken quetiapine for the treatment of first episode schizophrenia.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

University of Regensburg, Department of Psychiatry; 🇩🇪 Regensburg, Germany