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| ID | Type | Description | Link |
|---|---|---|---|
| HR-10762 |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.
Objective: To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms.
Research Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy.
Intervention: Eligible patients will be randomized to receive quetiapine starting at 25 mg daily or matching placebo. Dose adjustments (to a minimum of 50 mg or a maximum of 800 mg), will be made at the investigator's discretion and according to patient's clinical response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Quetiapine |
|
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | Drug | Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Week 12 scores on Positive and Negative Syndrome Scale (PANSS) | ||
| Hamilton Depression Rating Scale (HAMD) | ||
| Hamilton Rating Scale of Anxiety (HAMA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark B Hamner, MD | Ralph H. Johnson VAMC/Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NM VA Healthcare System | Albuquerque | New Mexico | 87108 | United States | ||
| Ralph H. Johnson VAMC |
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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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| Placebo | Drug | Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS. |
|
| Clinical Global Impression Severity Scale (CGI-S) |
| Clinical Global Impression Improvement Scale (CGI-I) |
| Davidson Trauma Scale (DTS) |
| Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A) |
| Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) |
| SDS |
| Arizona Sexual Experience Scale (ASEX) |
| AIMS |
| BAS |
| SAS |
| Charleston |
| South Carolina |
| 29401 |
| United States |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |