Obsessive Compulsive Disorder Clinical Trial
Official title:
Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder
Verified date | April 2012 |
Source | Neuropharm |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Neuropharm |
United States,
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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