Generalized Anxiety and Seroquel (GAD)
Primary Purpose
Generalized Anxiety Disorder, Seroquel XR
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seroquel XR
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Seroquel, Generalized Anxiety Disorder, fMRI
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent
- Fluency in English
- A diagnosis of GAD
- No pregnancy
- Right-handedness
- Psychotropic medication-free at the start of the study
Exclusion Criteria:
- Pregnancy or lactation
- Any current DSM-IV-TR Axis I disorder
- Any mental retardation or cognitive impairment that precludes informed consent
- Known intolerance or lack of response to quetiapine fumarate
- Substance or alcohol dependence at enrollment
- Participation in another drug trial within 4 weeks prior enrollment
- History of allergic reaction or hypersensitivity to Seroquel or Seroquel XR
- History of prior Seroquel or other antipsychotic agents use
- Contraindications to magnetic resonance imaging
- Treatment with an effective medication for GAD
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Seroquel XR
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.
Changes in anxiety symptomatolgy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01066143
Brief Title
Generalized Anxiety and Seroquel
Acronym
GAD
Official Title
Pharmacotherapy of Generalized Anxiety Disorder With Seroquel: Normalization of Brain Stress and Reward Function
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
The underwriter stopped the funding
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be combined with fMRI experiments.
Detailed Description
Subjects will be recruited from clinic patients and known research subjects at McLean Hospital, as well as by advertisements in the media, flyers, and word of mouth. An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. Subjects will be also screened for drug use. If no obvious health problems are present, subjects will be scheduled for an evaluation. Upon arrival at the research unit, each subject will first complete a standardized interview schedule designed to obtain personal and background data such as age, marital status, socio-economic status, education, employment, etc. The Research Assistant will give subjects both verbal and written descriptions of the study procedures. After briefing subjects on the reasons for the research, subjects will be given the opportunity to ask questions. When they are ready, subjects will be asked to sign the written informed consent form approved by the Mclean Institutional Review Board (IRB). Functional magnetic resonance imaging scans to examine brain functioning will be obtained from GAD patients (N=30) at baseline and after 12 weeks. Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Seroquel XR
Keywords
Seroquel, Generalized Anxiety Disorder, fMRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seroquel XR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Seroquel XR
Intervention Description
Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
Primary Outcome Measure Information:
Title
Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.
Description
Changes in anxiety symptomatolgy
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provision of written informed consent
Fluency in English
A diagnosis of GAD
No pregnancy
Right-handedness
Psychotropic medication-free at the start of the study
Exclusion Criteria:
Pregnancy or lactation
Any current DSM-IV-TR Axis I disorder
Any mental retardation or cognitive impairment that precludes informed consent
Known intolerance or lack of response to quetiapine fumarate
Substance or alcohol dependence at enrollment
Participation in another drug trial within 4 weeks prior enrollment
History of allergic reaction or hypersensitivity to Seroquel or Seroquel XR
History of prior Seroquel or other antipsychotic agents use
Contraindications to magnetic resonance imaging
Treatment with an effective medication for GAD
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Generalized Anxiety and Seroquel
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