Generalized Anxiety and Seroquel

NCT ID: NCT01066143

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-02-28

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.

Conditions

Generalized Anxiety Disorder; Seroquel XR

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Seroquel XR

Group Type: EXPERIMENTAL

Seroquel XR

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Igor Elman, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

2009-P-001662

Identifier Type: -

Identifier Source: org_study_id