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

Tracking Information
First Received Date ^ICMJE	August 10, 2007
Last Updated Date	April 26, 2012
Start Date ^ICMJE	July 2007
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 26, 2012)	The change in OCD symptoms using CY-BOCS [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: August 10, 2007)	The change in OCD symptoms using CY-BOCS [ Time Frame: Throughout the study ]
Change History	Complete list of historical versions of study NCT00515255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 26, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 10, 2007)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of NPL-2003 in Adolescents With Obsessive Compulsive Disorder (OCD)
Official Title ^ICMJE	Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Obsessive Compulsive Disorder
Intervention ^ICMJE	Drug: Minocycline Capsules
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	6
Completion Date	April 2008
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	12 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00515255
Other Study ID Numbers ^ICMJE	NPL-2003-1-POCD-001
Has Data Monitoring Committee	Not Provided
Responsible Party	Neuropharm
Study Sponsor ^ICMJE	Neuropharm
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Neuropharm
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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