Obsessive Compulsive Disorder
Conditions
Keywords
Obsessive Compulsive Disorder, Neuropharm, NPL-2003
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.
Interventions
DRUGMinocycline
Capsules
Sponsors
Neuropharm
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in OCD symptoms using CY-BOCS | Throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | Throughout the study |
| Multidimensional Anxiety Scale for Children (MASC) | Throughout the study |
| Global Assessment Scale for Children (CGAS) | Throughout the study |
| Columbia Suicide-Severity Rating Scale (SSRS) | Throughout the study |
Countries
United States
Outcome results
None listed