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

NCT01933919 | Completed Phase 3 Results

• 1 other identifier: M13-970
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder; Adolescent Subjects; Pediatric Subjects

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the Japanese Children's Yale-Brown Obsessive Compulsive Scale 10-item Total Score at the End of Treatment in the First Phase

  The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD) in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.

  Baseline and week 10

Secondary Outcomes (11)

• Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age

  Baseline and week 10

• Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender

  Baseline and week 10

• Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase

  Baseline and weeks 2, 4, 6, 8 and 10

• JCY-BOCS 10-item Total Score at Each Visit During the First Phase

  Baseline and weeks 2, 4, 6, 8 and 10

• Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase

  Weeks 1, 2, 3, 4, 5, 6, 8, and 10

Study Arms (2)

placebo

PLACEBO COMPARATOR

In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum of three tablets twice a day. From weeks 7 to 10 participants received the same dose that was given during week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.

Drug: Fluvoxamine maleate; Drug: Placebo

Fluvoxamine

EXPERIMENTAL

In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given during week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.

Drug: Fluvoxamine maleate

Interventions

Fluvoxamine maleate DRUG

Film-coated tablet containing 25 mg of fluvoxamine maleate

Also known as: SME3110, Luvox, Depromel

Fluvoxamine; placebo

Placebo DRUG

Placebo tablet matching to fluvoxamine maleate

placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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).
• Subject has obsessive compulsive disorder symptoms at least for 2 months at informed consent.
• Body weight: ≥ standard weight - 2 standard deviation based on the standard weight for each age in the School Health Statistical Survey 2001.
• 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).

You may not qualify if:

• 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.
• 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.
• 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.
• Subject who diagnose Major Depressive Disorder by The Mini-International Neuropsychiatric Interview for Children and Adolescents (A) at the Screening period.
• 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.

Sponsors & Collaborators

• AbbVie: lead
• Meiji Seika Pharma Co., Ltd.: collaborator

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Susumu Matsuki, BS

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 2, 2013
• Study Start: August 14, 2013
• Primary Completion: June 18, 2015
• Study Completion: July 1, 2016
• Last Updated: December 4, 2017
• Results First Posted: December 4, 2017

Record last verified: 2017-06