Clinical trial NCT01066143: Generalized Anxiety and Seroquel
Official title: Pharmacotherapy of Generalized Anxiety Disorder With Seroquel: Normalization of Brain Stress and Reward Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Generalized Anxiety Disorder
Seroquel XR
Keywords: Seroquel
Generalized Anxiety Disorder
fMRI
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
References: