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NCT01695291 · ClinicalTrials.gov registry record · Phase 2
Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01695291 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 31 participants.
The verdict
NCT01695291, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study 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 2:1 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.
Interventions
- OTHER Placebo
- DRUG Minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2012-05 |
| Est. Completion | 2018-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01695291
The ClinicalTrials.gov registry entry for NCT01695291 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01695291 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01695291 about?
NCT01695291 is a clinical study titled "Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD". 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 sig...
What is the current status of trial NCT01695291?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2012-05. Estimated completion is 2018-05.
What interventions are being tested in trial NCT01695291?
The interventions under investigation include: Placebo (OTHER), Minocycline (DRUG).
Who is sponsoring clinical trial NCT01695291?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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