Ignite Creation Date:
2024-05-06 @ 12:57 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01695291
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2012-09-21
Brief Title:
Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
A Randomized Placebo-controlled Trial of Minocycline Added to Serotonin Reuptake Inhibitors in Pediatric OCD Examining the Effects on Clinical Symptoms and on Brain Glutamate Levels Using MRS Imaging
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the feasibility and potential efficacy of augmenting SRIs with minocycline The study will assess whether the addition of minocycline leads to measurable changes in striatal glutamate Glu levels This study will recruit up to 45 youth ages 8-20 diagnosed with clinically significant OCD who have demonstrated no more than minimal response to SRI treatment and are currently on a stable dose of SRI medication for at least 12 weeks Participants will be randomized to receive either 12 weeks of minocycline treatment or pill placebo Randomization will be 21 so that 2 of 3 participants receive minocycline Screening for eligibility will take place for 1-4 weeks Participants will undergo magnetic resonance spectroscopy MRS scans to measure striatal Glu levels prior to randomization and again immediately following the treatment period During the treatment period participants will meet initially weekly and then every other week with the study psychiatrist All participants will be offered three months of open medication treatment following participation The clinical trial will only be conducted at the New York State Psychiatric Institute NYSPI and the MRS scans may be conducted at Weill Cornell Medical Center or NYSPI
Detailed Description:
Please see the brief summary for study description
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34MH095502-03 | NIH | None | httpsreporternihgovquickSearchR34MH095502-03 |