Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT00751504
Eligibility Criteria:
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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00751504
Study Brief:
Protocol Section:
NCT00751504