Brain Imaging of Quetiapine Response in Anxious Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Intervention: quetiapine (Seroquel XR)
Intervention description: Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Depression; Anxiety; Seroquel; Quetiapine; fMRI; pictures

Summary:

      The purpose of this study is to find out what parts of the brain have increased or decreased
      connectivity when people are depressed and how Seroquel extended release (XR) changes this
      connectivity in depressed patients. The genetic samples collected are to look at variation in
      a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin
      in the brain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent

          -  A diagnosis of Major Depressive Episode by Diagnostic and Statistical Manual of Mental
             Disorders- Fourth Edition (DSM-IV)

          -  Females or Males aged 18 - 60 years

          -  Female subjects of childbearing potential must be using a reliable method of
             contraception and have a negative serum human chorionic gonadotropin (HCG) test at
             enrollment

          -  Able to understand and comply with the requirements of the study

          -  17-item Hamilton Depression Rating Scale (HDRS) score > 15

          -  Hamilton Anxiety Scale (HAM-A) score > 15

          -  Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire

          -  Able to be managed as outpatients for initial assessment and during treatment as
             ascertained by the following:

               -  Symptoms not worsening by more than 10 points on the HDRS during the course of
                  the study.

               -  No danger to self or others.

        Exclusion Criteria:

          -  Pregnancy or lactation

          -  Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective
             disorder, atypical psychosis, mental retardation, or organic mental (including organic
             mood) disorder

          -  Subjects 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, St. John's Wort, and glucocorticoids

          -  Administration of a depot antipsychotic injection within one dosing interval (for the
             depot) before randomisation

          -  Substance or alcohol dependence at enrollment (except dependence in full remission,
             and except for caffeine or nicotine dependence), as defined by DSM-IV criteria

          -  Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV
             criteria within four weeks prior to enrollment

          -  Medical conditions that would affect absorption, distribution, metabolism, or
             excretion of study treatment

          -  Unstable or inadequately treated medical illness (angina pectoris, hypertension) as
             judged by the investigator

          -  Involvement in the planning and conduct of the study

          -  Previous enrollment or randomization of treatment in the present study.

          -  Participation in another drug trial within four weeks prior enrollment into this study
             or longer in accordance with local requirements

          -  A subject with Diabetes Mellitus; people who develop hyperglycemia will be removed
             from the study

          -  An absolute neutrophil count (ANC) of 1.5 x 109 per liter

          -  Use of psychotropics in the past two weeks. If on fluoxetine in the past, then should
             not have been on this medication for four weeks.

          -  History of lack of response to Quetiapine extended release.

          -  Acutely suicidal or homicidal or requiring inpatient treatment.

          -  Metallic implants.