- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01200901
Quetiapine in Melancholic Depression
January 16, 2013 updated by: Erik Nelson, University of Cincinnati
Quetiapine in Melancholic Depression: an fMRI Study of Treatment-induced Changes in the Neurocircuitry of the Stress Response
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:
- quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features
- 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.
- 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)
Study Overview
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 initial fMRI scanning session prior to the initiation of quetiapine XR.
Baseline fMRI will be obtained during the index assessment prior to initiating quetiapine XR therapy and then will be re-acquired at the final study visit at 8 weeks (the time of scheduled visits).
Ten demographically matched healthy subjects will receive the same fMRI investigations on two occasions in order to provide a healthy baseline comparison to permit interpretation of the patient findings (e.g., whether initial and final fMRI measures in patients are abnormal and to control for any adaptation to the task that may normally occur).
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Melancolic depression patients
Patients with major depression will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing).
|
quetiapine XR 100 - 300 mg (flexible dosing)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features
Time Frame: 8 weeks
|
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 initial fMRI scanning session prior to the initiation of quetiapine XR.
Baseline fMRI will be obtained during the index assessment prior to initiating quetiapine XR therapy and then will be re-acquired at the final study visit at 8 weeks (the time of scheduled visits).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
normalization of limbic areas associated with increased salivary cortisol response to a stressful task
Time Frame: 8 Weeks
|
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.
|
8 Weeks
|
successful treatment with quetiapine XR will be associated with normalization of the salivary cortisol response to the stressful math task
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Erik Nelson, MD, University of Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
September 7, 2010
First Submitted That Met QC Criteria
September 13, 2010
First Posted (Estimate)
September 14, 2010
Study Record Updates
Last Update Posted (Estimate)
January 18, 2013
Last Update Submitted That Met QC Criteria
January 16, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nelson AZ-IIT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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