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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)
Information provided by (Responsible Party):
Neuropharm Identifier:
First received: August 10, 2007
Last updated: April 26, 2012
Last verified: April 2012
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: 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

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

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
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Please refer to this study by its identifier: NCT00515255

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
  More Information

Responsible Party: Neuropharm Identifier: NCT00515255     History of Changes
Other Study ID Numbers: NPL-2003-1-POCD-001
Study First Received: August 10, 2007
Last Updated: April 26, 2012

Keywords provided by Neuropharm:
Obsessive Compulsive Disorder

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior
Anti-Bacterial Agents
Anti-Infective Agents processed this record on April 21, 2017