Quetiapine in Melancholic Depression
NCT01200901 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2013-01-18
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. quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features
2. successful treatment with quetiapine XR will be associated with normalization of limbic areas associated with increased salivary cortisol response to a stressful task as well as normalization on the emotional faces task differences in the melancholic group compared with healthy volunteers.
3. successful treatment with quetiapine XR will be associated with normalization of the salivary cortisol response to the stressful math task (i.e. there will be a diminished post-treatment mean AUC for cortisol secretion after the stress task compared to the pre-treatment AUC values in the patient group)
Conditions
- Depression
- Healthy
Interventions
- DRUG
-
Quetiapine
quetiapine XR 100 - 300 mg (flexible dosing)
Sponsors & Collaborators
-
University of Cincinnati
lead OTHER
Principal Investigators
-
Erik Nelson, MD · University of Cincinnati
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-09-30
- Primary Completion
- 2012-09-30
- Completion
- 2012-09-30
Countries
- United States
Study Locations
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