Status:
COMPLETED
Quetiapine in the Treatment of Psychotic Depression - a Pilot Study
Lead Sponsor:
Ruhr University of Bochum
Conditions:
Psychotic Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Atypical antipsychotics have been found not only to be beneficial in the treatment of psychotic disorders, but even for depressive symptoms in patients with schizophrenia. Remarkably, preliminary data...
Eligibility Criteria
Inclusion
- 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
Exclusion
- pregnancy or lactation
- any DSM-IV Axis I disorder not defined in the inclusion criteria or not in full remission
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00751504
Start Date
September 1 2008
End Date
July 1 2012
Last Update
January 24 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LWL University Hospital Bochum of the Ruhr-University Bochum
Bochum, North Rhine-Westphalia, Germany, 44791