Obsessive Compulsive DisorderPhase 2NCT00515255
Study of NPL-2003 in Adolescents With Obsessive Compulsive Disorder (OCD)
A Phase 2 study testing Minocycline in people with Obsessive Compulsive Disorder, run by Neuropharm at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Minocycline
- Type of treatment
- Pill or oral medicine
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Case Medical Center
Cleveland, Ohio, 44106-5080
New York State Psychiatric Institute, Columbia University
New York, New York, 10032
About this study
Official title: Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder
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.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Minocycline
- Keywords
- Obsessive Compulsive Disorder, Neuropharm, NPL-2003
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Capsules
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in OCD symptoms using CY-BOCS
Measured: Throughout the study
Secondary outcomes (7)
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Measured: Throughout the study
NIMH Global OC Scale
Measured: Throughout the study
Clinical Global Impressions of Improvement (CGI-I)
Measured: Throughout the study
The Children's Depression Rating Scale (CDRS-R)
Measured: Throughout the study
Columbia Suicide-Severity Rating Scale (SSRS)
Measured: Throughout the study
Multidimensional Anxiety Scale for Children (MASC)
Measured: Throughout the study
Global Assessment Scale for Children (CGAS)
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Recruitment Goal of 20 Not Met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuropharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515255
- Sponsor's protocol ID
- NPL-2003-1-POCD-001
- Status last verified
- Apr 2012
- First submitted
- 10 Aug 2007
- Last updated
- 27 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00515255
- Acronym / sponsor ID
- NPL-2003-1-POCD-001
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Obsessive Compulsive Disorder, Neuropharm, NPL-2003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment Goal of 20 Not Met
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NeuropharmIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineCapsules | Drug | – |
Primary outcome
The change in OCD symptoms using CY-BOCS
Time frame: Throughout the study
7 secondary outcomes
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time frame: Throughout the study
NIMH Global OC Scale
Time frame: Throughout the study
Clinical Global Impressions of Improvement (CGI-I)
Time frame: Throughout the study
The Children's Depression Rating Scale (CDRS-R)
Time frame: Throughout the study
Columbia Suicide-Severity Rating Scale (SSRS)
Time frame: Throughout the study
Multidimensional Anxiety Scale for Children (MASC)
Time frame: Throughout the study
Global Assessment Scale for Children (CGAS)
Time frame: Throughout the study
Results and safety
The study was stopped early (reason given: Recruitment Goal of 20 Not Met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
- www.neuropharm.co.ukLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline in people with Obsessive Compulsive Disorder, run by Neuropharm at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment Goal of 20 Not Met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in OCD symptoms using CY-BOCS (time frame: Throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.