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

April 26, 2012 updated by: Neuropharm

Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute, Columbia University
    • Ohio
      • Cleveland, Ohio, United States, 44106-5080
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in OCD symptoms using CY-BOCS
Time Frame: Throughout the study
Throughout the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuropharm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 10, 2007

First Submitted That Met QC Criteria

August 10, 2007

First Posted (Estimate)

August 13, 2007

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPL-2003-1-POCD-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obsessive Compulsive Disorder

Clinical Trials on Minocycline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe