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

This study has been terminated.
(Recruitment Goal of 20 Not Met)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515255
First Posted: August 13, 2007
Last Update Posted: April 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neuropharm
  Purpose
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.

Condition Intervention Phase
Obsessive Compulsive Disorder Drug: Minocycline Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Neuropharm:

Primary Outcome Measures:
  • The change in OCD symptoms using CY-BOCS [ Time Frame: Throughout the study ]

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

Enrollment: 6
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Minocycline
    Capsules
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515255


Locations
United States, New York
New York State Psychiatric Institute, Columbia University
New York, New York, United States, 10032
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106-5080
Sponsors and Collaborators
Neuropharm
  More Information

Responsible Party: Neuropharm
ClinicalTrials.gov Identifier: NCT00515255     History of Changes
Other Study ID Numbers: NPL-2003-1-POCD-001
First Submitted: August 10, 2007
First Posted: August 13, 2007
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Neuropharm:
Obsessive Compulsive Disorder
Neuropharm
NPL-2003

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents