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Study of NPL-2003 in Adolescents With Obsessive Compulsive Disorder (OCD)

Primary Purpose

Obsessive Compulsive Disorder

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Minocycline
Sponsored by
Neuropharm
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder, Neuropharm, NPL-2003

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets DSM-IV criteria for Obsessive Compulsive Disorder.
  • CY-BOCS score of greater or equal to 16 at screening.
  • NIMH Global OC Scale score of 7 or higher at screening.

Exclusion Criteria:

  • Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
  • Autistic Disorder or Pervasive Developmental Disorder.
  • Moderate or severe mental retardation.
  • Severe renal insufficiency.

Other protocol-defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • New York State Psychiatric Institute, Columbia University
  • University Hospitals Case Medical Center

Outcomes

Primary Outcome Measures

The change in OCD symptoms using CY-BOCS

Secondary Outcome Measures

The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
NIMH Global OC Scale
Clinical Global Impressions of Improvement (CGI-I)
The Children's Depression Rating Scale (CDRS-R)
Columbia Suicide-Severity Rating Scale (SSRS)
Multidimensional Anxiety Scale for Children (MASC)
Global Assessment Scale for Children (CGAS)

Full Information

First Posted
August 10, 2007
Last Updated
April 26, 2012
Sponsor
Neuropharm
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1. Study Identification

Unique Protocol Identification Number
NCT00515255
Brief Title
Study of NPL-2003 in Adolescents With Obsessive Compulsive Disorder (OCD)
Official Title
Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
Recruitment Goal of 20 Not Met
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuropharm

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of NPL-2003 on the symptoms of Obsessive Compulsive Disorder (OCD) in an adolescent population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Obsessive Compulsive Disorder, Neuropharm, NPL-2003

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Description
Capsules
Primary Outcome Measure Information:
Title
The change in OCD symptoms using CY-BOCS
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time Frame
Throughout the study
Title
NIMH Global OC Scale
Time Frame
Throughout the study
Title
Clinical Global Impressions of Improvement (CGI-I)
Time Frame
Throughout the study
Title
The Children's Depression Rating Scale (CDRS-R)
Time Frame
Throughout the study
Title
Columbia Suicide-Severity Rating Scale (SSRS)
Time Frame
Throughout the study
Title
Multidimensional Anxiety Scale for Children (MASC)
Time Frame
Throughout the study
Title
Global Assessment Scale for Children (CGAS)
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets DSM-IV criteria for Obsessive Compulsive Disorder. CY-BOCS score of greater or equal to 16 at screening. NIMH Global OC Scale score of 7 or higher at screening. Exclusion Criteria: Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment. Autistic Disorder or Pervasive Developmental Disorder. Moderate or severe mental retardation. Severe renal insufficiency. Other protocol-defined Inclusion/Exclusion criteria may apply.
Facility Information:
Facility Name
New York State Psychiatric Institute, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5080
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.neuropharm.co.uk
Description
www.neuropharm.co.uk

Learn more about this trial

Study of NPL-2003 in Adolescents With Obsessive Compulsive Disorder (OCD)

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