An interventional study of Seroquel XR in Generalized Anxiety Disorder and Seroquel XR, sponsored by Mclean Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by Mclean Hospital · Not applicable, Interventional, and Treatment
The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be combined with fMRI experiments.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 8 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Mclean Hospital is the lead sponsor of 181 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.
Changes in anxiety symptomatolgy
Time frame: 12 week
| Milestone | Seroquel XR |
|---|---|
| Started | 8 |
| Completed | 0 |
| Not completed | 8 |
| Withdrew: Ineligible for the study | 8 |
Changes in anxiety symptomatolgy
| Measure | Seroquel XR |
|---|---|
| Change From Baseline in GAD Symptomatology at the Week 12 Timepoint. | 0 |
Collected over No adverse events collected. 8 subjects signed the consent but were later found to be ineligible; the study didn't start. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Seroquel XR | — | — | — |
8 subjects signed the consent but were later found to be ineligible; therefore the study didn't start
| Age, Categorical | Seroquel XR |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male | Seroquel XR |
|---|---|
| Female | 0 |
| Male | 0 |
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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