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NCT00515255 Clinical Trial

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

Obsessive Compulsive Disorder Clinical Trial

Official title:
Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00515255
Other study ID # NPL-2003-1-POCD-001
Secondary ID
Status Terminated
Phase Phase 2
First received August 10, 2007
Last updated April 26, 2012
Start date July 2007
Est. completion date April 2008

Study information
Verified date April 2012
Source Neuropharm
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Minocycline
Capsules

Locations
Country Name City State
United States University Hospitals Case Medical Center Cleveland Ohio
United States New York State Psychiatric Institute, Columbia University New York New York

Sponsors (1)
Lead Sponsor Collaborator
Neuropharm

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change in OCD symptoms using CY-BOCS Throughout the study No
Secondary The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Throughout the study No
Secondary NIMH Global OC Scale Throughout the study No
Secondary Clinical Global Impressions of Improvement (CGI-I) Throughout the study No
Secondary The Children's Depression Rating Scale (CDRS-R) Throughout the study No
Secondary Columbia Suicide-Severity Rating Scale (SSRS) Throughout the study No
Secondary Multidimensional Anxiety Scale for Children (MASC) Throughout the study No
Secondary Global Assessment Scale for Children (CGAS) Throughout the study No
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