Generalized Anxiety and Seroquel

Generalized Anxiety Disorder Clinical Trial

— GAD  

Official title:

Pharmacotherapy of Generalized Anxiety Disorder With Seroquel: Normalization of Brain Stress and Reward Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01066143
• Other study ID #: 2009-P-001662
• Status: Terminated
• Phase: N/A
• First received: February 8, 2010
• Last updated: October 24, 2013
• Start date: February 2010
• Est. completion date: February 2013

Study information

• Verified date: October 2013
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be combined with fMRI experiments.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder
• Seroquel XR

Intervention

Drug:
• Seroquel XR
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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the change from baseline in GAD symptomatology at the Week 12 timepoint.		12 week	No
Primary	Change from baseline GAD symptomatology at the Week 12 timepoint.		12 weeks	No