Generalized Anxiety and Seroquel

Not Applicable

Terminated

• Conditions: Generalized Anxiety Disorder; Seroquel XR
• Interventions: Drug: Seroquel XR

• Registration Number: NCT01066143
• Lead Sponsor: Mclean Hospital

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-10
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2017-04
• Results First Submitted: 2017-04-07
• Results First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Results First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seroquel XR	Seroquel XR	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.	12 week	Changes in anxiety symptomatolgy

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States