Study of NPL-2003 in Adolescents With Obsessive Compulsive Disorder (OCD)
Phase 2
Terminated
- Conditions
- Obsessive Compulsive Disorder
- Registration Number
- NCT00515255
- Lead Sponsor
- Neuropharm
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The change in OCD symptoms using CY-BOCS Throughout the study
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
New York State Psychiatric Institute, Columbia University
🇺🇸New York, New York, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States