Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients
This study has been completed.
Sponsor:
University of Regensburg
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
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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 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Quetiapine Induced Neuroplasticity in Schizophrenic Patients: A Combined Transcranial Magnetic Stimulation (TMS) and Voxel-based Morphometry (VBM) Study |
Resource links provided by NLM:
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 ]
| Enrollment: | 30 |
| Study Start Date: | March 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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
Locations
| Germany | |
| 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 |
More Information
No publications provided
| Responsible Party: | Goeran Hajak, Prof. Dr. med., University of Regensburg |
| ClinicalTrials.gov Identifier: | NCT00554658 History of Changes |
| Other Study ID Numbers: | D1443L00015 |
| Study First Received: | November 6, 2007 |
| Last Updated: | October 21, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Quetiapine Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013