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Brain Imaging of Quetiapine Response in Anxious Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00982345
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: quetiapine (Seroquel XR) Phase 4

Detailed Description:
This study will measure the activity and connectivity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with seroquel.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain Imaging of Quetiapine Response in Anxious Depression
Study Start Date : March 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Open label Quetiapine
Open-label Quetiapine XL 50 - 400 mg daily treatment 8 weeks
Drug: quetiapine (Seroquel XR)
Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
Other Name: Seroquel XR

Primary Outcome Measures :
  1. 17-item Hamilton Depression Rating Scale (HDRS) [ Time Frame: Started: March 2009 Ending March 2011 ]
    Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00982345

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United States, Indiana
Indiana University Adult Psychiatry Clinic
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
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Principal Investigator: Amit Anand, MD Indiana University School of Medicine
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Responsible Party: Indiana University School of Medicine Identifier: NCT00982345    
Other Study ID Numbers: 0901-13
First Posted: September 23, 2009    Key Record Dates
Results First Posted: September 30, 2016
Last Update Posted: September 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Indiana University ( Indiana University School of Medicine ):
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs