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

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. Identifier: NCT00515255
Recruitment Status : Terminated (Recruitment Goal of 20 Not Met)
First Posted : August 13, 2007
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: Minocycline Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Study Start Date : July 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Minocycline

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

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

Information from the National Library of Medicine

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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.

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 identifier (NCT number): 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

Responsible Party: Neuropharm Identifier: NCT00515255     History of Changes
Other Study ID Numbers: NPL-2003-1-POCD-001
First Posted: August 13, 2007    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Neuropharm:
Obsessive Compulsive Disorder

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