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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

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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00515255
NPL-2003-1-POCD-001
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