BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder

Inclusion Criteria:

• Patients with a primary diagnosis of PTSD according to DSM-IV criteria (PosttraumaticStress Disorder: 309.81). In order to diagnose PTSD, the Clinician-Administered PTSDScale-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 underthe age of 20, his/her parent/guardian must also give his/her written informedconsent.

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 toDSM-IV criteria within 24 weeks prior to Week -1. However, patients with depressivedisorders are allowed to enroll in the study, if PTSD was present before thedepressive disorders appeared and PTSD is the predominant disorder.

• Patients presenting a current major depressive episode that preceded the diagnosis ofPTSD. However, patients with depressive disorders are allowed to enroll in the study,if PTSD was present before the depressive disorders appeared and PTSD is thepredominant disorder.

• Patients receiving disability payments because of PTSD or any other psychiatricdisorder.

• Patients currently engaged in compensation litigation whereby personal gain would beachieved 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 substancedependence within 24 weeks prior to Week -1.

• Patients who have attempted suicide within 24 weeks prior to Week -1 or who pose, inthe investigator's judgement using the M.I.N.I. "C. Suicidality", a high suicidalrisk.

• Women who are pregnant or lactating, who may be pregnant, or who plan for pregnancyduring the study.

• Patients who have taken MAO inhibitors within 1 week prior to Week -1 (or within 2weeks 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 priorto 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 orhematopoietic 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%.