Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
This study is currently recruiting participants.
Verified April 2013 by New York State Psychiatric Institute
Sponsor:
New York State Psychiatric Institute
Collaborators:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Moira A. Rynn, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01695291
First received: September 21, 2012
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
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 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 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 NYSPI and the MRS scans may be conducted at Weill Cornell Medical Center or NYSPI.
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive Compulsive Disorder |
Drug: Minocycline Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by New York State Psychiatric Institute:
Primary Outcome Measures:
- Yale-Brown Obsessive Compulsive Scale, Child version (CYBOCS) [ Time Frame: Change from Baseline at 4, 8, and 12 weeks ] [ Designated as safety issue: No ]The CYBOCS is a semi-structured measure of OCD severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20. The CYBOCS differs from the adult YBOCS only in its use of simpler language.
Secondary Outcome Measures:
- Striatal glutamate level measured by MRS. [ Time Frame: Change from Baseline at 12 weeks ] [ Designated as safety issue: No ]The change in striatal glutamate level will be assessed.
| Estimated Enrollment: | 45 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
|
Other: Placebo
A placebo pill will be administered BID for 12 weeks.
|
|
Experimental: Minocycline Augmentation
Those randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline (minimum 50 mg/day and maximum 200 mg/day). After randomization, participants will receive child proofed bottles that contain enough study medication until the next visit with an additional 3 days coverage in case of scheduling issues. All participants will have a minocycline level drawn at week 12 to confirm treatment adherence. Minocycline is FDA-approved in those ages 8 and above for treatment of infections and acne and has a favorable risk-benefit profile.
|
Drug: Minocycline
Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks.
Other Name: Minomycin, Minocin, Arestin, Aknemin, Solodyn and Dynacin
|
Detailed Description:
Please see the brief summary for study description.
Eligibility| Ages Eligible for Study: | 8 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants must be ages of 8-20 at the time of consent
- Participants must weigh at least 25kg
- Participants and a parent/guardian must be able to read and understand English
- Participants must meet diagnostic criteria for obsessive-compulsive disorder with score ≥ 16 on the Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS)
- Participants must be on stable dose of serotonin reuptake inhibitor (SRI) medication, and must have had an adequate trial of SRI medication
- Report of at least minimal, but not full, response to current SRI medication to warrant ongoing SRI treatment
- For participants younger than 18, written informed assent by the participant and consent by the parent. For participants 19 and older, written consent by the participant and permission for legal guardian/parent to provide information
Exclusion Criteria:
- Medical or psychiatric conditions that would make participation in the study unsafe
- Active suicidal ideation
- Females who are using hormonal birth control
- Presence of metallic device or dental braces incompatible with MRS
- IQ <80
- OCD patients with primary symptoms of hoarding (determined by CYBOCS checklist)
- Current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
- Participant is currently receiving CBT, other forms of psychotherapy, or psychotropic medications other than SRI medication
- Documented history of hypersensitivity or intolerance to tetracycline antibiotics
- Use of medications that are contra-indicated with minocycline (e.g., concomitant use of antacids, iron, calcium, magnesium, aluminum, zinc salts as they impair minocycline absorption; of anti-coagulant drugs as minocycline has been shown to depress plasma prothrombin activity; of other antibiotics or Accutane due to the rare side effect of pseudotumor cerebri)
- Inability of participant or parent/guardian to read or understand English
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695291
Contacts
| Contact: Moira Rynn, M.D. | (212) 543-4506 | RynnM@nyspi.columbia.edu |
| Contact: Amy Rapp, BA | (212) 543-5592 | RappAmy@nyspi.columbia.edu |
Locations
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Moira Rynn, M.D. 212-543-4506 RynnM@nyspi.columbia.edu | |
| Contact: Amy Rapp, BA (212) 543-5592 RappAmy@nyspi.columbia.edu | |
| Principal Investigator: Moira Rynn, M.D. | |
| Sub-Investigator: Helen Blair Simpson, M.D. | |
| Weill Cornell Medical Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Dikoma Shungu, Ph.D. 212-746-2481 dcs7001@med.cornell.edu | |
| Sub-Investigator: Dikoma Shungu, Ph.D. | |
Sponsors and Collaborators
New York State Psychiatric Institute
Weill Medical College of Cornell University
Investigators
| Principal Investigator: | Moira A Rynn, MD | Columbia University/NYSPI |
More Information
No publications provided
| Responsible Party: | Moira A. Rynn, Associate Professor of Clinical Psychiatry, New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT01695291 History of Changes |
| Other Study ID Numbers: | 6574, R34MH095502-01 |
| Study First Received: | September 21, 2012 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by New York State Psychiatric Institute:
|
Obsessive compulsive disorder |
Additional relevant MeSH terms:
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Minocycline Serotonin Uptake Inhibitors Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013