Quetiapine in Melancholic Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Healthy Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | September 2008 |
| End Date: | September 2012 |
| Contact: | Tracey Adleta |
| Email: | adletaty@ucmail.uc.edu |
| Phone: | 513-558-3249 |
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:
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)
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).
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.
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