Quetiapine in the Treatment of Psychotic Depression - a Pilot Study

Inclusion Criteria

• •provision of written informed consent
• •diagnosis of depression with psychotic features by DSM-IV (296.23, 296.33)
• •females and males aged 18 to 65 years
• •female patients of childbearing potential must be using a reliable method of contraception and have a negative pregnancy test at enrollment
• •patients must be able to understand and comply with the requirements of the study
• •MADRS score above 20 points
• •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, as judged by the investigator
• •use of any cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment
• •use of any cytochrome P450 inducers in the 14 days preceding enrollment
• •thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range at enrollment
• •administration of a depot antipsychotic injection within one dosing interval before randomisation
• •substance or alcohol dependence at enrollment, as defined by DSM-IV
• •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
• •risk of transmitting human immunodeficiency virus (HIV) or hepatitis B via blood or other body fluids
• •unstable or inadequately treated medical illness, as judged by the investigator
• •patients with diabetes mellitus (DM)
• •an absolute neutrophil count (ANC) \< 1.5x10E9 per liter
• •history of idiopathic orthostatic hypotension, or condition that would predispose to
• •ECG considered to show clinically significant abnormalities at enrollment as determined by a cardiologist
• •involvement in the planning and conduct of the study
• •previous enrollment or randomisation of treatment in the present study
• •any serious and unstable somatic illness that, in the opinion of the investigator, would be negatively affects by the study medication
• •participation in another drug trial within 4 weeks prior to enrollment into this study
• •patients with unsufficient knowledge of the German language