Study Stopped
The underwriter stopped the funding
Generalized Anxiety and Seroquel
GAD
Pharmacotherapy of Generalized Anxiety Disorder With Seroquel: Normalization of Brain Stress and Reward Function
1 other identifier
interventional
8
1 country
1
Brief Summary
The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be combined with fMRI experiments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
May 17, 2017
CompletedMay 17, 2017
April 1, 2017
3 years
February 8, 2010
April 7, 2017
April 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.
Changes in anxiety symptomatolgy
12 week
Study Arms (1)
Seroquel XR
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mclean Hospitallead
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
8 subjects signed the consent but were later found to be ineligible; the study didn't start
Results Point of Contact
- Title
- Igor Elman, PI
- Organization
- McLean
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 10, 2010
Study Start
February 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
May 17, 2017
Results First Posted
May 17, 2017
Record last verified: 2017-04