Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Intervention: paroxetine 10mg tablet; paroxetine 20mg tablet; matched placebo to paroxetine 10mg; matched placebo to paroxetine 20mg
Intervention description: 1 or 2 tablet(s) once a day; 1 tablet once a day; 2 tablets once a day; 1 tablet once a day
Intervention MeSH terms: Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: paroxetine; selective serotonin reuptake inhibitor; CDRS-R; children and adolescents

Summary:

      This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial
      dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in
      children and adolescents with major depressive disorder (MDD) based on the change from
      baseline to Week 8/end-of-study in the CDRS-R total score in a randomized, double-blind,
      placebo-controlled parallel-group study.
    

Eligibility criteria:

        Inclusion Criteria:

        run-in period: A subject will be considered eligible for the study only if all of the
        following criteria apply at start of placebo run-in period.

          -  Patients who are diagnosed with the following depressive disorders according to the
             DSM-IV-TR criteria, and currently presents with a depressive episodes. Depressive
             disorders: MDD, single episode (296.2), MDD, recurrent (296.3)

          -  7 years and older and under 18 years old (at the time of consent obtained)

          -  Patients with a total raw summary score on the CDRS-R of 45 or greater at the Week -2
             visit.

          -  Patients whose legally acceptable representative (e.g., caretaker, custodian) is able
             to give written consent to participation to this study. Patients aged 12 and above at
             the time of consent obtained should be able to sign the informed consent on one's own.
             Efforts should be exerted in obtaining the informed assent in writing from patients
             aged less than 12.

          -  Patients with ideal body weight +/- 2SD

          -  Gender: Male or female

        treatment period:

        Subjects who meet the following criteria at Week 0 (Baseline) may be progressed to the
        Treatment period:

        - Patients with a total raw summary score on the CDRS-R at Week 0 visit of 45 or greater.

        Exclusion Criteria

        run-in period:

        A subject will not be eligible for inclusion to this study if any of the following criteria
        applies at start of run-in period:

          -  Patients who in the investigator's judgment presented with a clinically predominant
             Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific
             phobia, PTSD, OCD, Panic disorder, etc)

          -  Patients with any history of a psychotic episode or psychotic disorder (including
             schizophrenia ), or complication of these diseases.

          -  Patients with a history of a bipolar disorder, or complication of these diseases.

          -  Patients with Attention-Deficit, or Hyperactivity Disorder

          -  Patients with Mental Retardation or Pervasive Development Disorder

          -  Patients diagnosed with Substance Abuse or Dependence within 12 weeks prior to the
             Screening visit

          -  Patients with past treatment experience with the investigational drug (i.e.
             paroxetine)

          -  Patients treated with electroconvulsive therapy in the immediate 12 weeks prior to the
             Screening visit

          -  Patients with past history of serotonin syndrome and neuroleptic malignant syndrome.

          -  Patients with CDRS-R score of "suicidal ideation" of 3 or greater. Or patients whose
             C-SSRS assessment suggests that they are or have been at significant risk for harming
             themselves or have actually harmed themselves, or who, in the opinion of the chief
             investigator (subinvestigator), are at significant risk for harming self.

          -  Patients with past history of suicide attempt, self harm(excluding "no suicidal intent
             " ), or an intentional overdose (excluding obviously unintentional overdose)

          -  Patients who have been treated with other clinical trial investigational drug
             (including post-marketing clinical trial) in the immediate past 3 months of the Week
             -2 visit.

          -  Patients who have taken antidepressant medication 1 week prior to screening.

          -  Patients with complicated disease of glaucoma.

          -  Patients with convulsive disorders such as epilepsy or past history of these diseases.

          -  Patients regularly using drugs (e.g. NSAIDs) that would increase the risk of
             haemorrhage, or patients with bleeding tendency or haemorrhagic diathesis.

          -  Patients with severe renal and hepatic disorder.

          -  Patients with serious organic disorder in the brain.

          -  Patients with chronic hepatitis type B and/or C which is positive of hepatitis B
             surface antigen (HBsAg) and/or hepatitis C antibody.

          -  Patients with a current history of carcinoma or malignant tumor, or complication of
             these diseases.

          -  Female patients who are pregnant, lactating, or who might be pregnant, or who wish to
             be pregnant during the study period

          -  Patients in the opinion of the chief investigator (subinvestigator) judged as not
             eligible for the study.

          -  Patients with clinical significant comorbid impulsivity symptoms.(e.g. Personality
             Disorder, Conduct Disorder)

        treatment period: Subjects for whom any of the following categories apply at Week 0 (start
        of the treatment period) will not be progressed to the treatment phase.

          -  Patients with CDRS-R score of "suicidal ideation" of 3 or greater, or patients who, in
             the opinion of the chief investigator (sub investigator), are at significant risk for
             harming self

          -  Patients with variation of the CDRS-R total raw summary score at Week 0 of +/-25% or
             greater compared to that of Week -2.

          -  Patients with drug compliance of Drug 1 (run-in placebo) from Week -2 to Week 0 less
             than 80%.

          -  Patients, in the opinion of the chief investigator (sub investigator) judged as not
             appropriate for the study.