Status:
COMPLETED
Quetiapine in Melancholic Depression
Lead Sponsor:
University of Cincinnati
Conditions:
Depression
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
In summary, the investigators propose to integrate fMRI assessments within a clinical trial of quetiapine XR in patients with melancholic depression in order to test the predictions that: 1. quetiapi...
Detailed Description
Patients with major depression (N=20) will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing). Patients who consent to participate will be referred for an initi...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Provision of written informed consent
- A diagnosis of major depression with melancholic features by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Females and males aged 18-65 years
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
- Able to understand and comply with the requirements of the study
- Subjects will have a Hamilton Depression Rating Scale, 28-item version (HDRS-28) score of at least 20 at the baseline visit.
- Exclusion criteria
- Pregnancy or lactation
- 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 fumarate, as judged by the investigator
- Use of any of the following cytochrome P450 3a4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
- Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including, but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, and St. John's Wort.
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation Women using oral contraceptives or other medications that directly affect estrogen or progesterone system in the body.
- Subjects taking corticosteroids or other medications that directly influence HPA axis function
- Subjects with certain lifestyle habits (i.e. working night shift) that could affect the function of the HPA axis
- History of substance dependence in the past year or meets criteria for a substance abuse disorder in the past three months.
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
- Participation in another drug trial within 4 weeks prior to enrollment into this study
- An absolute neutrophil count (ANC) of 1.5 x 109 per liter
- Patients who have initiated a new psychotherapy or behavioral therapy from a mental health professional in the past 3 months
- A lifetime DSM-IV history of a psychotic disorder, a bipolar disorder, or dementia.
- History of psychosurgery
- Axis II disorder
- History of seizures, excluding febrile seizures in childhood.
- Clinically relevant abnormal laboratory results.
- Patients who have received monoamine oxidase inhibitors, tricyclics, SSRIs, antipsychotics, or lithium within two weeks prior to randomization, or fluoxetine within four weeks prior to randomization.
- Electroconvulsive therapy (ECT) within three months of start of study
- History of mental retardation.
- History of major neurological illness, including any history of significant head trauma.
- Contraindications to magnetic resonance imaging, including claustrophobia and/or the presence of ferrous material that might make an MRI scan hazardous.
- Patients will be excluded from the study if they indicate at screening that they know someone who has previously participated in the study.
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01200901
Start Date
September 1 2008
End Date
September 1 2012
Last Update
January 18 2013
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45219