A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Fluvoxamine maleate; Placebo
Intervention description: Film-coated tablet containing 25 mg of fluvoxamine maleate; Placebo tablet matching to fluvoxamine maleate
Intervention MeSH terms: Fluvoxamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Obsessive Compulsive Disorder; Adolescent Subjects; Pediatric Subjects

Summary:

      The objective of the first phase of this study is to evaluate the efficacy of fluvoxamine
      compared to placebo on change in total score of Japanese version of the Children's Yale-Brown
      Obsessive Compulsive Scale (JCY-BOCS) 10-item from baseline to the last observation visit (10
      weeks) in pediatric/adolescent participants with obsessive compulsive disorder (OCD).

      The objective of the second phase of the study is to evaluate the long-term safety and
      efficacy of fluvoxamine in pediatric/adolescent patients with OCD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has at least 16 points on Japanese version of the Children's Yale-Brown
             Obsessive Compulsive Scale 10-item total score and at least 5 points in Obsession
             sub-total score and in Compulsion sub-total score respectively at the Screening period
             and Baseline.

          2. Subject showed less than 25% reduction in Japanese version of the Children's
             Yale-Brown Obsessive Compulsive Scale 10-item total score at Baseline compared to the
             score at the Screening period (Total score at Baseline ≥ Total score at Screening х
             0.75).

          3. Subject has obsessive compulsive disorder symptoms at least for 2 months at informed
             consent.

          4. Body weight: ≥ standard weight - 2 standard deviation based on the standard weight for
             each age in the School Health Statistical Survey 2001.

          5. Subjects with parent or legal guardian who have received explanation about the
             purpose, procedure and meaning of the study sufficiently and is willing to give
             written informed consent for the subject. (if possible, written informed assent will
             be obtained from the subject).

        Exclusion Criteria:

          1. Subject has only trichotillomania (Diagnostic and Statistical manual of Mental
             Disorders Forth Edition Text Revision: 312.39) or nail-biting as his/her compulsive
             symptoms.

          2. Subject has Tourette's disorder (Diagnostic and Statistical manual of Mental Disorders
             Forth Edition Text Revision: 307.23). However, the simple motor tic is not excluded.

          3. Subject is diagnosed with the following psychiatric disorders.

               -  Schizophrenia (Diagnostic and Statistical manual of Mental Disorders Forth
                  Edition Text Revision: 295.xx) and other psychotic disorders (Diagnostic and
                  Statistical manual of Mental Disorders Forth Edition Text Revision: 295.40
                  [schizophreniform disorder], 295.70 [schizoaffective disorder], 297.1 [delusional
                  disorder], 298.8 [brief psychotic disorder], 297.3 [shared psychotic disorder],
                  293.xx [psychotic disorder due to… {indicate the general medical condition}],
                  substance induced psychotic disorder, 298.9 [psychotic disorder not otherwise
                  specified]).

               -  Depressive disorders Diagnostic and Statistical manual of Mental Disorders Forth
                  Edition Text Revision: 296.xx [major depressive disorder], 296.2x [single
                  episode], 296.3x [recurrent], 300.4 [dysthymic disorder], 311 [depressive
                  disorder not otherwise specified]).

               -  Bipolar disorders (Diagnostic and Statistical manual of Mental Disorders Forth
                  Edition Text Revision: 296.xx [bipolar I disorder], 296.0x [single manic
                  episode], 296.40 [most recent episode hypomanic], 296.4x [most recent episode
                  manic], 296.6x [most recent episode mixed], 296.5x [most recent episode
                  depressed], 296.7 [most recent episode unspecified], 296.89 [bipolar II
                  disorder], 301.13 [cyclothymic disorder], 296.80 [bipolar disorder not otherwise
                  specified]).

               -  Mental retardation (Diagnostic and Statistical manual of Mental Disorders Forth
                  Edition Text Revision: 317 [mild mental retardation], 318.0 [moderate mental
                  retardation], 318.1 [severe mental retardation], 318.2 [profound mental
                  retardation], 319 [mental retardation, severity unspecified]).

               -  Eating disorders (Diagnostic and Statistical manual of Mental Disorders Forth
                  Edition Text Revision: 307.1 [anorexia nervosa], 307.51 [bulimia nervosa], 307.50
                  [eating disorder not otherwise specified]).

               -  Attention-deficit/hyperactivity disorder (Diagnostic and Statistical manual of
                  Mental Disorders Forth Edition Text Revision: 314.xx) and attention
                  deficit/hyperactivity disorder not otherwise specified (Diagnostic and
                  Statistical manual of Mental Disorders Forth Edition Text Revision: 314.9).

               -  Obsessive compulsive personality disorder (Diagnostic and Statistical manual of
                  Mental Disorders Forth Edition Text Revision: 301.4).

               -  Other patients with clinical neurological disorder.

          4. Subject who diagnose Major Depressive Disorder by The Mini-International
             Neuropsychiatric Interview for Children and Adolescents (A) at the Screening period.

          5. Subject has been treated with fluvoxamine within 2 months prior to informed consent.
             Except for the patient whose fluvoxamine dose is not fixed and the administration
             period of fluvoxamine is within 6 weeks.