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This was a 52-week, non-comparative, uncontrolled study of paroxetine in Japanese PTSD patients to obtain clinical experience regarding efficacy and safety. In this study, subjects received paroxetine 20mg-40mg once daily after an evening meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxetine | Other | A 52-week, non-comparative, uncontrolled study (However, the baseline phase is single blind) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine | Drug | Subjects will take the treatment phase medication once daily after an evening meal. All subjects will be maintained at Dose Level II (20 mg/day) for the first 2 weeks. If a sufficient clinical response ("1. Very much improved" or "2. Much improved" based on the CGI Global Improvement) is achieved, the subject will continue on the same dose level. When the clinical response is not sufficient but the investigational product is well tolerated, the dose will be increased to Dose Level III (30 mg/day) and then to Dose Level IV (40 mg/day) at intervals of at least 2 weeks until a sufficient response is reached. Once a sufficient response is obtained, the treatment will be continued at that dose. The treatment phase will last for a total of 52 weeks. In those patients receiving Dose Level III or IV, dosage reductions to the next lowest level (Dose Level II or III) consequent to an adverse event are permitted. Dosage adjustment will be made at the discretion of the PI or Sub-PI |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale One Week Symptom Status Version (CAPS-SX) total score | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders based on the CGI Global Improvement | 52 weeks | |
| Change from baseline in the CAPS-SX re-experiencing cluster score | 52 weeks | |
| Change from baseline in the CAPS-SX avoidance/numbing cluster score |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria at Week -1
Exclusion Criterion at Week 0
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19068000 | Background | Kim Y, Asukai N, Konishi T, Kato H, Hirotsune H, Maeda M, Inoue H, Narita H, Iwasaki M. Clinical evaluation of paroxetine in post-traumatic stress disorder (PTSD): 52-week, non-comparative open-label study for clinical use experience. Psychiatry Clin Neurosci. 2008 Dec;62(6):646-52. doi: 10.1111/j.1440-1819.2008.01862.x. |
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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 |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 52 weeks |
| Change from baseline in the CAPS-SX hyperarousal cluster score | 52 weeks |
| Change from baseline in the CGI Severity of Illness score | 52 weeks |
| Adverse events (AEs), abnormal findings in each examination/test, and their details: Laboratory tests (hematology, clinical chemistry, electrolytes, urinalysis), Blood pressure, pulse rate, body weight | 52 weeks |