Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Quetiapine in Melancholic Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erik Nelson, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01200901
First received: September 7, 2010
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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)

Condition Intervention Phase
Depression
Healthy
Drug: Quetiapine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quetiapine in Melancholic Depression: an fMRI Study of Treatment-induced Changes in the Neurocircuitry of the Stress Response

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • normalization of limbic areas associated with increased salivary cortisol response to a stressful task [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: Quetiapine
quetiapine XR 100 - 300 mg (flexible dosing)
Other Name: Open Label Quetiapine

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200901

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Erik Nelson, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Erik Nelson, Adjunct Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01200901     History of Changes
Other Study ID Numbers: Nelson AZ-IIT
Study First Received: September 7, 2010
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
depression
healthy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014