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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.
Full description
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
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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:
Other Psychiatric disorders not in full remission, concomitant organic mental disorder or mental retardation
Patients who, in the investigators judgement, pose an imminent risk of suicide or a danger to self or others
Hamilton Depression Rating Scale<7 points
Female patients who are pregnant, lactating or at risk of pregnancy
Female patients who are not using a highly effective method of birth control. A highly effective method of birth control is defined as those which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implantants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under investigation and its potential effect on the contraception must be addressed.
history of idiopathic orthostatic hypotension, or condition that would predispose to (dehydration, hypovolaemia)
Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B and C, via blood or other body fluids
history of non-compliance as judged by the investigator
Patients with substance dependence. A urine drug screen will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets the DSM-IV criteria for substance dependence
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.
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Data sourced from clinicaltrials.gov
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