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

August 10, 2007
April 26, 2012
July 2007
April 2008   (final data collection date for primary outcome measure)
The change in OCD symptoms using CY-BOCS [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
The change in OCD symptoms using CY-BOCS [ Time Frame: Throughout the study ]
Complete list of historical versions of study NCT00515255 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Study of NPL-2003 in Adolescents With Obsessive Compulsive Disorder (OCD)
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obsessive Compulsive Disorder
Drug: Minocycline
Capsules
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
April 2008
April 2008   (final data collection date for primary outcome measure)

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.

Both
12 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00515255
NPL-2003-1-POCD-001
Not Provided
Not Provided
Not Provided
Neuropharm
Neuropharm
Not Provided
Not Provided
Neuropharm
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP