A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder

Inclusion Criteria:

1. Subject has at least 16 points on Japanese version of the Children's Yale-BrownObsessive Compulsive Scale 10-item total score and at least 5 points in Obsessionsub-total score and in Compulsion sub-total score respectively at the Screening periodand Baseline.

2. Subject showed less than 25% reduction in Japanese version of the Children'sYale-Brown Obsessive Compulsive Scale 10-item total score at Baseline compared to thescore 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 informedconsent.

4. Body weight: ≥ standard weight - 2 standard deviation based on the standard weight foreach age in the School Health Statistical Survey 2001.

5. Subjects with parent or legal guardian who have received explanation about thepurpose, procedure and meaning of the study sufficiently and is willing to givewritten informed consent for the subject. (if possible, written informed assent willbe obtained from the subject).

Exclusion Criteria:

1. Subject has only trichotillomania (Diagnostic and Statistical manual of MentalDisorders Forth Edition Text Revision: 312.39) or nail-biting as his/her compulsivesymptoms.

2. Subject has Tourette's disorder (Diagnostic and Statistical manual of Mental DisordersForth 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 ForthEdition Text Revision: 295.xx) and other psychotic disorders (Diagnostic andStatistical manual of Mental Disorders Forth Edition Text Revision: 295.40 [schizophreniform disorder], 295.70 [schizoaffective disorder], 297.1 [delusionaldisorder], 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 otherwisespecified]).

• Depressive disorders Diagnostic and Statistical manual of Mental Disorders ForthEdition Text Revision: 296.xx [major depressive disorder], 296.2x [singleepisode], 296.3x [recurrent], 300.4 [dysthymic disorder], 311 [depressivedisorder not otherwise specified]).

• Bipolar disorders (Diagnostic and Statistical manual of Mental Disorders ForthEdition Text Revision: 296.xx [bipolar I disorder], 296.0x [single manicepisode], 296.40 [most recent episode hypomanic], 296.4x [most recent episodemanic], 296.6x [most recent episode mixed], 296.5x [most recent episodedepressed], 296.7 [most recent episode unspecified], 296.89 [bipolar IIdisorder], 301.13 [cyclothymic disorder], 296.80 [bipolar disorder not otherwisespecified]).

• Mental retardation (Diagnostic and Statistical manual of Mental Disorders ForthEdition Text Revision: 317 [mild mental retardation], 318.0 [moderate mentalretardation], 318.1 [severe mental retardation], 318.2 [profound mentalretardation], 319 [mental retardation, severity unspecified]).

• Eating disorders (Diagnostic and Statistical manual of Mental Disorders ForthEdition 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 ofMental Disorders Forth Edition Text Revision: 314.xx) and attentiondeficit/hyperactivity disorder not otherwise specified (Diagnostic andStatistical manual of Mental Disorders Forth Edition Text Revision: 314.9).

• Obsessive compulsive personality disorder (Diagnostic and Statistical manual ofMental Disorders Forth Edition Text Revision: 301.4).

• Other patients with clinical neurological disorder.

4. Subject who diagnose Major Depressive Disorder by The Mini-InternationalNeuropsychiatric 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 administrationperiod of fluvoxamine is within 6 weeks.