Post-Traumatic Stress Disorder
Conditions
Brief summary
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.
Interventions
DRUGParoxetine
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
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a primary diagnosis of PTSD according to DSM-IV criteria (Posttraumatic Stress Disorder: 309.81). In order to diagnose PTSD, the Clinician-Administered PTSD Scale-DX Current and Lifetime Diagnostic Version (CAPS-DX) will be used. * Disease to Be Treated: * Duration of illness of at least 3 months at Week -1. * Score \>= 50 on Criteria B, C and D of CAPS-SX. * Age: \>=18 - \<65 years (at the time of acquisition of informed consent) * Sex: No restriction * Hospitalization Status: No restriction * Informed consent: Gives his/her informed consent. In case of a subject who is under the age of 20, his/her parent/guardian must also give his/her written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale One Week Symptom Status Version (CAPS-SX) total score | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the CAPS-SX re-experiencing cluster score | 52 weeks |
| Change from baseline in the CAPS-SX avoidance/numbing cluster score | 52 weeks |
| Proportion of responders based on the CGI Global Improvement | 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 |
| Change from baseline in the CAPS-SX hyperarousal cluster score | 52 weeks |
Outcome results
None listed