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This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.
An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. If no obvious counterindications are present, subjects will be scheduled for a screening visit. After briefing the subjects on the reasons for the research, they will be given an opportunity to read the Informed Consent Form, approved by the Cambridge Health Alliance Institutional ReviewBoard, and to ask questions prior to signing it. Subjects will be given a copy of the signed Consent Form. Each subject will complete a standardized interview schedule designed to obtain personal and background data along with psychodiagnostic and psychometric evaluations. An open-label treatment will be utilized for all patients. Seroquel tablets will be flexibly dosed and begun at a target dose of 25 mg per day and taken over an 8 week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seroquel | Experimental | This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seroquel | Drug | This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint. | We will compare patients' symptomatology at baseline vs. at 8 week timepoint Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS) Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136 For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor Elman, MD | CHA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Street Health Center | Somerville | Massachusetts | 02143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Seroquel | This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Seroquel | This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 PTSD Symptomatology at the Week 8 Timepoint. | We will compare patients' symptomatology at baseline vs. at 8 week timepoint Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS) Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136 For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed | It was predicted that patients will show a change in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS). | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
4 years
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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 | This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Igor Elman | Cambridge Health Alliance | (617) 665-1000 | ielman@challiance.org |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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|
|
| 0 |
| 34 |
| 0 |
| 34 |
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| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |