Study of NPL-2003 in Adolescents With Obsessive Compulsiv... | NCT00515255

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

NCT00515255

Sponsor

Neuropharm

Status

Terminated

Last Update Posted

Apr 27, 2012Estimated

Enrollment

6Actual

Phase

Phase 2

Conditions

Obsessive Compulsive Disorder

Interventions

Minocycline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment Goal of 20 Not Met

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Aug 10, 2007

First Submission Date that Met QC Criteria

Aug 10, 2007

First Posted Date

Aug 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2012

Last Update Posted Date

Apr 27, 2012Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Name	Type	Description	Arm Group Labels	Other Names
Minocycline	Drug	Capsules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in OCD symptoms using CY-BOCS		Throughout the study

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York State Psychiatric Institute, Columbia University		New York	New York	10032	United States

Condition Browse Module

MeSH Terms

ID	Term
D009771	Obsessive-Compulsive Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008911	Minocycline

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided