Clinical trial NCT00557622 (phase 2, status: terminated)
Conditions: post-traumatic stress disorder, stress disorders, post-traumatic
ICD codes: F43.10, F43.11, F43.12, F43.10, F43.11, F43.12
Drugs: paroxetine
SMILES: FC1=CC=C(C=C1)[C@@H]1CCNC[C@H]1COC1=CC2=C(OCO2)C=C1
Reason stopped: 
    difficulty in achieving target enrollment numbers
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are primarily diagnosed with PTSD (Posttraumatic Stress Disorder: 309.81)
             using DSM-IV-TR criteria. The CAPS-DX (Clinician-Administered PTSD Scale-DX) and
             M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0.
             [2003]) will be used for diagnosis

          -  Pathologic condition: Patients who experienced a motor vehicle accident (MVA) with
             severe or potential severe physical injury more than 3 months ago but less than 12
             months ago

          -  Patients aged 20 and <65 at the time of signing the Informed consent

          -  Male and female patients

          -  Inpatient/outpatient status: Both are permitted

          -  Patients who are able to give written informed consent in person (i.e., patients who
             are capable of giving written informed consent on their own)

          -  Patients whose combined score of the CAPS-SX standard B, C, and D is over 50

        Exclusion Criteria:

          -  Patients primarily diagnosed with a DSM-IV-TR Axis I disorder other than PTSD (e.g.
             major depressive disorder, dysthymic disorder, specific phobia [simple phobia],
             obsessive-compulsive disorder, panic disorder, etc.) within 6 months of week -4 (start
             of baseline phase)

          -  Patients presenting with a current major depressive episode that preceded the
             diagnosis of PTSD

          -  Patients receiving disability payments due to PTSD or other psychiatric diseases

          -  Patients currently engaged in compensation litigation whereby personal gain would be
             achieved from prolonged symptoms of PTSD or any other psychiatric disorders

          -  Patients who meet the DSM-IV-TR criteria for substance abuse or dependence (alcohol or
             drugs) within 6 months of Week -4 (start of baseline phase)

          -  Patients with history of a suicide attempt within 6 months before Week -4 (start of
             baseline phase), or have, in the opinion of the investigator, "C. high risk of
             suicide" according to the MINI at Week -4

          -  Patients who are pregnant, lactating or of childbearing potential and are likely to
             become pregnant

          -  Patients receiving electro-convulsive therapy (ECT) prior to Week -4 (start of
             baseline phase)

          -  Patients receiving another investigational product within 12 weeks before Week -4
             (start of baseline phase)

          -  Patients with a history or complication of manic psychosis

          -  Patients with a history or complication of convulsive disorder (epilepsy, etc.)

          -  Patients with a diagnosis or complication of a cognitive disorder (MMSE <=24 points)

          -  Patients with a history and complication of serious cerebral organic disorder. (e.g.
             cerebrovascular disorder, meningitis, degenerative disease and other neurological
             disorders and seizures; however, bleeding in the upper arachnoid membrane should not
             be excluded)

          -  Patients unable or unwilling to undergo the fMRI procedure (e.g., cerebrovascular
             clipping surgery, pacemaker, any internal metals with magnetism, and claustrophobia)

          -  Patients with glaucoma

          -  Patients with a known tendency for bleeding or those with predisposing conditions

          -  Patients with a history of hypersensitivity to paroxetine

          -  Patients with serious physical symptoms (cardiac, hepatic and renal dysfunction, or
             hematopoietic dysfunction, etc.). For seriousness, Grade 3 of "Criteria for
             seriousness of adverse reactions to drugs, etc. (Yakuan No.80)" is used as an index

          -  Patients with a history or complication of cancer or malignant tumour

          -  Patients with chronic hepatitis type B and/or C which is positive of hepatitis B
             surface antigen (HBsAg) and/or hepatitis C antibody

          -  Others whom the investigator or sub-investigator considers ineligible for or unable to
             participate in the investigation

          -  Criteria at Week 0 (start of Treatment Phase):

        Subjects whose drug compliance rate for Drug 1 (Run-in Phase placebo) is <80% between Week
        -4 and Week 0;

        Subjects whose CAPS-SX total score of the standard B, C, and D at Week 0 varied by 25% or
        more compared with those at Week -2