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

Sponsor

Neuropharm (Industry)

Overall Status

Terminated

CT.gov ID

NCT00515255

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jul 1, 2007

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Outcome Measures

Primary Outcome Measures

The change in OCD symptoms using CY-BOCS [Throughout the study]

Secondary Outcome Measures

The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [Throughout the study]
NIMH Global OC Scale [Throughout the study]
Clinical Global Impressions of Improvement (CGI-I) [Throughout the study]
The Children's Depression Rating Scale (CDRS-R) [Throughout the study]
Columbia Suicide-Severity Rating Scale (SSRS) [Throughout the study]
Multidimensional Anxiety Scale for Children (MASC) [Throughout the study]
Global Assessment Scale for Children (CGAS) [Throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute, Columbia University	New York	New York	United States	10032
2	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106-5080