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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:
Information provided by (Responsible Party):
Neuropharm
ClinicalTrials.gov Identifier:
NCT00515255
First received: August 10, 2007
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Neuropharm:

Primary Outcome Measures:
  • The change in OCD symptoms using CY-BOCS [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • NIMH Global OC Scale [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Clinical Global Impressions of Improvement (CGI-I) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • The Children's Depression Rating Scale (CDRS-R) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Columbia Suicide-Severity Rating Scale (SSRS) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Global Assessment Scale for Children (CGAS) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
www.neuropharm.co.uk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Neuropharm
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Minocycline
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013