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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seroquel XR | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seroquel XR | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in GAD Symptomatology at the Week 12 Timepoint. | Changes in anxiety symptomatolgy | 12 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
8 subjects participated in screening but later were found to be ineligible for study participation
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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8 subjects signed the consent but were later found to be ineligible; therefore the study didn't start
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 8 subjects signed the consent but were later found to be ineligible |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in GAD Symptomatology at the Week 12 Timepoint. | Changes in anxiety symptomatolgy | 8 subjects signed the consent but were later found to be ineligible; the study didn't start | Posted | 12 week |
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No adverse events collected. 8 subjects signed the consent but were later found to be ineligible; the study didn't start
8 subjects signed the consent but were later found to be ineligible; the study didn't start
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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8 subjects signed the consent but were later found to be ineligible; the study didn't start
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Igor Elman, PI | McLean | (800) 333-0338 | ielman@partners.org |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Sex: Female, Male | 8 subjects signed the consent but were later found to be ineligible |
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