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Sponsors and Collaborators: |
Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH University of Göttingen |
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Information provided by: | Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH |
ClinicalTrials.gov Identifier: | NCT00511277 |
The purpose of this study is:
To investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in treating depressive symptoms.
To investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in mania-like symptoms and to evaluate the general efficacy in psychopathology as well as the safety and tolerability of quetiapine.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Seroquel® |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Single-Arm, Open-Label and Multicenter Phase IV Study: Efficacy and Safety of Quetiapine in Treating Affective Symptoms of Patients With First-Episode Psychosis - a Pilot Study |
Estimated Enrollment: | 60 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Affective symptoms, in particular depressive symptoms are prevalent in up to 60% of all patients with schizophrenia. However, it is still uncertain whether depressive symptoms have a prognostic value, having previously been associated with both favorable and poor outcome. In addition, treatment of affective symptoms in patients with schizophrenia is difficult. There is some evidence that atypical antipsychotics such as quetiapine may contribute not only to a reduction in psychotic symptoms but also that these agents may produce an antidepressant effect in schizophrenia and may reduce suicidality. Most of these studies suffer from methodological limitations as the efficacy on affective symptoms has not been the primary target parameter. Concerning the prevalence of affective symptoms in first-episode psychosis knowledge is still poor. This is why we have developed a study design for a pilot-study on 60 patients with first-episode schizophrenia aiming to demonstrate that a treatment with quetiapine over the period of 6 months shows clinical efficacy on affective, particularly depressive symptoms
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients who meet the following inclusion criteria are eligible to participate in the study:
Exclusion Criteria:
Patients who meet one or more of the following exclusion criteria cannot participate in the study:
Patients with known diabetes mellitus or impaired glucose tolerance, especially a patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
Contact: Peter Falkai, MD PhD | ++49(0)551 396601 | pfalkai@gwdg.de |
Contact: Alexander Berg | ++49(0)551 3913497 | berg.ifs@med.uni-goettingen.de |
Germany | |
Department of Psychiatry and Psychotherapy, GEORG-AUGUST-UNIVERSITY GÖTTINGEN | Recruiting |
Göttingen, Germany | |
Contact: Peter Falkai, MD PhD ++49(0)551 396601 pfalkai@gwdg.de | |
Contact: Alexander Berg ++49(0)551 3913498 berg.ifs@med.uni-goettingen.de |
Study Director: | Peter Falkai, MD PhD | Department of Psychiatry and Psychotherapy, GEORG-AUGUST-UNIVERSITY GÖTTINGEN, GERMANY |
Principal Investigator: | Thomas Wobrock, MD PhD | Department of Psychiatry and Psychotherapy, GEORG-AUGUST-UNIVERSITY GÖTTINGEN, GERMANY |
Principal Investigator: | Andreas Heinz, MD PhD | Department of Psychiatry and Psychotherapy, Charité Campus Mitte Berlin, Germany |
Principal Investigator: | Georg Juckel, MD PhD | Department of Psychiatry, Ruhr University Bochum, Germany |
Responsible Party: | University Hospital of Göttingen ( Prof. Peter Falkai, MD PhD ) |
Study ID Numbers: | D1449L00016 |
Study First Received: | August 2, 2007 |
Last Updated: | January 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00511277 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
quetiapine schizophrenia first-episode psychosis depression psychopathology |
Schizophrenia Quetiapine Depression Mental Disorders Psychotic Disorders |
Affective Symptoms Depressive Disorder Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |