Clinical trial NCT00839397: BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder
Official title: BRL29060A in Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Exclusion Criteria:

Exclusion Criteria at Week -1

* Patients diagnosed with Axis I disorders (excluding PTSD) such as major depression, dysthymia, simple phobia, OCD, or panic disorder as a primary diagnosis according to DSM-IV criteria within 24 weeks prior to Week -1. However, patients with depressive disorders are allowed to enroll in the study, if PTSD was present before the depressive disorders appeared and PTSD is the predominant disorder.
* Patients presenting a current major depressive episode that preceded the diagnosis of PTSD. However, patients with depressive disorders are allowed to enroll in the study, if PTSD was present before the depressive disorders appeared and PTSD is the predominant disorder.
* Patients receiving disability payments because of PTSD or any other psychiatric disorder.
* Patients currently engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.
* Patients taking St. Johns Wort.
* Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 24 weeks prior to Week -1.
* Patients who have attempted suicide within 24 weeks prior to Week -1 or who pose, in the investigator's judgement using the M.I.N.I. "C. Suicidality", a high suicidal risk.
* Women who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study.
* Patients who have taken MAO inhibitors within 1 week prior to Week -1 (or within 2 weeks prior to Week 0).
* Patients who have had electroconvulsive therapy (ECT) within 12 weeks prior to Week -1.
* Patients who have been treated with another investigational drug within 12 weeks prior to Week -1.
* Patients with a history or complication of manic psychosis.
* Patients with a history or complication of convulsive disorder (epilepsy, etc.).
* Patients with a complication of glaucoma.
* Patients with a known tendency for bleeding or those with predisposing conditions.
* Patients with a history of hypersensitivity to paroxetine.
* Patients with any serious organic disorder in the brain.
* Patients with any serious physical symptom such as cardiac, hepatic, renal or hematopoietic dysfunction.
* Patients with a history or complication of cancer or malignant tumor.
* Others whom the investigator or sub-investigator considers ineligible for the study.

Exclusion Criterion at Week 0

* Patients whose placebo run-in medication compliance is less than 80%.

Primary outcomes:
measure: Change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale One Week Symptom Status Version (CAPS-SX) total score
timeFrame: 52 weeks
Secondary outcomes:
measure: Proportion of responders based on the CGI Global Improvement
timeFrame: 52 weeks
measure: Change from baseline in the CAPS-SX re-experiencing cluster score
timeFrame: 52 weeks
measure: Change from baseline in the CAPS-SX avoidance/numbing cluster score
timeFrame: 52 weeks
measure: Change from baseline in the CAPS-SX hyperarousal cluster score
timeFrame: 52 weeks
measure: Change from baseline in the CGI Severity of Illness score
timeFrame: 52 weeks
measure: 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
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.