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A Phase 3 Study of SME3110 in Pediatric/Adolescent Subjects With Obsessive Compulsive Disorder

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obsessive Compulsive Disorder

Intervention: fluvoxamine maleate (Drug); placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AbbVie

Official(s) and/or principal investigator(s):
Susumu Matsuki, BS, Study Director, Affiliation: AbbVie GK

Summary

The objective in 1st phase of this randomized study is to evaluate the efficacy of SME3110 compared to placebo on change in total score of Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale 10-item for children from baseline to the last observation visit in pediatric/adolescent Obsessive Compulsive Disorder subjects in short-term (10 weeks) in double blind period. The safety of SME3110 compared to placebo is also evaluated. The objective in 2nd phase of the study is to evaluate the long-term safety and efficacy of SME3110 in pediatric/adolescent Obsessive Compulsive Disorder subjects.

Clinical Details

Official title: A Phase 3 Study of SME3110 (Fluvoxamine Maleate) in Pediatric/Adolescent Subjects With Obsessive Compulsive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Mean change of the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score.

Frequency of Adverse Events

Mean change of the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score.

Frequency of Adverse Events

Secondary outcome:

Mean change of the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score stratified by each factor

Mean change of the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score and subscore at each measurement

Clinical Global Impression Improvement

The proportion of subject with a ≥ 25% decrease from baseline in the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score

The proportion of subject with a ≥ 35% decrease from baseline in the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score

The change from baseline to each post-baseline measurement in the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score

Clinical Global Impression

Change of Laboratory test result, Body weight, Blood pressure and Pulse rate

Change of Laboratory test result, Body weight, Blood pressure and Pulse rate, and Electrocardiography

A change in Frequency of Withdrawn Syndrome

A change in Frequency of Withdrawn Syndrome

The Children's Yale-Brown Obsessive Compulsive Scale 10-item total score and sub-score

Detailed description: The 1st phase will be conducted in a randomized, placebo-controlled, double-blind manner to evaluate the efficacy of SME3110 on change from baseline to the last observation visit in Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score. Eligible patients will be allocated in SME3110 group or placebo group with 1: 1 ratio using the experience of fluvoxamine treatment and age as the stratification factor (dynamic allocation). The 1st phase consists of 5 periods; screening period of 1-2 weeks, forced titration dose period of 2 weeks, dose adjustment period of 4 weeks, maintained dose period of 4 weeks, and tapering dose period of 0-4 weeks. The 2nd phase will be conducted in an open-label manner in patients who completed the 1st phase to evaluate long-term safety of SME3110. The 2nd phase consists of 3 periods; forced titration dose period of 2 week, flexible dose period of 50 weeks, and tapering dose period of 0-4 weeks. After the last dose of study drug (including tapering dose period) or the early termination visit, subjects will be followed up to 30 days.

Eligibility

Minimum age: 6 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Subject has at least 16 scores in Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale 10-item total score and at least 5 scores 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 prior to informed consent.

4. Body weight: ≥ standard weight - 2 standard deviation based on the standard weight

for each age in the School Health Statistical Survey. 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 as 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 those who the fluvoxamine dose is not stable and the administration period of fluvoxamine is within 6 weeks.

Locations and Contacts

Site Reference ID/Investigator# 105819, Eiheiji-cho, Japan

Site Reference ID/Investigator# 112837, Fuchu-shi, Japan

Site Reference ID/Investigator# 105823, Fukuoka-shi, Japan

Site Reference ID/Investigator# 112839, Fukuoka, Japan

Site Reference ID/Investigator# 126799, Hamamatsu-shi, Japan

Site Reference ID/Investigator# 105820, Hokkaido, Japan

Site Reference ID/Investigator# 105821, Hyogo, Japan

Site Reference ID/Investigator# 105822, Ichikawa-shi, Japan

Site Reference ID/Investigator# 112835, Kagawa, Japan

Site Reference ID/Investigator# 112842, Kanagawa, Japan

Site Reference ID/Investigator# 105817, Kashihara-shi, Japan

Site Reference ID/Investigator# 132913, Kawasaki-shi, Japan

Site Reference ID/Investigator# 130488, Kishiwada-shi, Japan

Site Reference ID/Investigator# 105826, Kobe-shi, Japan

Site Reference ID/Investigator# 132914, Kurashiki-shi, Japan

Site Reference ID/Investigator# 130492, Kyoto-shi, Japan

Site Reference ID/Investigator# 130491, Machida-shi, Japan

Site Reference ID/Investigator# 105816, Moriguchi-shi, Japan

Site Reference ID/Investigator# 112836, Nagoya, Japan

Site Reference ID/Investigator# 105818, Nishinomiya-shi, Japan

Site Reference ID/Investigator# 126801, Oita-shi, Japan

Site Reference ID/Investigator# 130489, Okinawa-shi, Japan

Site Reference ID/Investigator# 112841, Osaka-shi, Japan

Site Reference ID/Investigator# 126798, Osaka-shi, Japan

Site Reference ID/Investigator# 105825, Saga, Japan

Site Reference ID/Investigator# 105824, Saitama, Japan

Site Reference ID/Investigator# 127031, Sakai-shi, Japan

Site Reference ID/Investigator# 127032, Sakai-shi, Japan

Site Reference ID/Investigator# 126797, Sapporo-shi, Japan

Site Reference ID/Investigator# 105815, Tochigi, Japan

Site Reference ID/Investigator# 112838, Tokyo, Japan

Site Reference ID/Investigator# 112840, Tokyo, Japan

Site Reference ID/Investigator# 129516, Tokyo, Japan

Site Reference ID/Investigator# 112843, Yokohama-shi, Japan

Site Reference ID/Investigator# 126800, Yokohama-shi, Japan

Additional Information

Starting date: August 2013
Last updated: April 15, 2015

Page last updated: August 23, 2015

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