Generalized Anxiety Disorder, Seroquel XR
Conditions
Keywords
Seroquel, Generalized Anxiety Disorder, fMRI
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.
Interventions
DRUGSeroquel 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.
Sponsors
Mclean Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in GAD Symptomatology at the Week 12 Timepoint. | 12 week | Changes in anxiety symptomatolgy |
Countries
United States
Participant flow
Pre-assignment details
8 subjects participated in screening but later were found to be ineligible for study participation
Participants by arm
| Arm | Count |
|---|---|
| Seroquel XR 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. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | ineligible for the study | 8 |
Baseline characteristics
| Characteristic | Seroquel XR |
|---|---|
| Age, Categorical <=18 years | 0 |
| Age, Categorical >=65 years | 0 |
| Age, Categorical Between 18 and 65 years | 0 |
| Sex: Female, Male Female | 0 |
| Sex: Female, Male Male | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.
Changes in anxiety symptomatolgy
Time frame: 12 week
Population: 8 subjects signed the consent but were later found to be ineligible; the study didn't start
| Arm | Measure | Value |
|---|---|---|
| Seroquel XR | Change From Baseline in GAD Symptomatology at the Week 12 Timepoint. | 0 |