NCT00515255

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

August 10, 2007

Last Update Submit

April 26, 2012

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive DisorderNeuropharmNPL-2003

Outcome Measures

Primary Outcomes (1)

  • The change in OCD symptoms using CY-BOCS

    Throughout the study

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

MinocyclineDRUG

Capsules

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York State Psychiatric Institute, Columbia University

New York, New York, 10032, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106-5080, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2007

First Posted

August 13, 2007

Study Start

July 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

US(2)