Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
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| ClinicalTrials.gov Identifier: NCT01695291 |
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Recruitment Status :
Active, not recruiting
First Posted : September 27, 2012
Last Update Posted : March 30, 2017
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Sponsor:
New York State Psychiatric Institute
Collaborators:
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Information provided by (Responsible Party):
New York State Psychiatric Institute
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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 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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Obsessive Compulsive Disorder | Drug: Minocycline Other: Placebo | Phase 2 |
Please see the brief summary for study description.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 33 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, 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 |
| Study Start Date : | May 2012 |
| Actual Primary Completion Date : | February 2017 |
| Estimated Study Completion Date : | March 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Obsessive-Compulsive Disorder
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
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Other: Placebo
A placebo pill will be administered BID for 12 weeks. |
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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.
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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 |
Primary Outcome Measures :
- Yale-Brown Obsessive Compulsive Scale, Child version (CYBOCS) [ Time Frame: Change from Baseline at 4, 8, and 12 weeks ]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 ]The change in striatal glutamate level will be assessed.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 8 Years to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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 a minimal 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 18 and older, written consent by the participant and permission for legal guardian/parent to provide information
Exclusion Criteria:
- Lifetime diagnosis of: psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, mental retardation, or substance/alcohol dependence
- Current diagnosis of major depressive disorder, Tourette's/Tic Disorder, or substance/alcohol abuse
- Positive urine screen for illicit drugs
- 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)
- Individuals who are currently receiving Exposure and Response Prevention therapy and are in the acute phase of treatment.
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695291
Locations
| United States, New York | |
| Weill Cornell Medical Center | |
| New York, New York, United States, 10021 | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Investigators
| Principal Investigator: | Moira A Rynn, M.D. | Columbia University/NYSPI |
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT01695291 History of Changes |
| Other Study ID Numbers: |
6574 R34MH095502-03 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 27, 2012 Key Record Dates |
| Last Update Posted: | March 30, 2017 |
| Last Verified: | March 2017 |
Keywords provided by New York State Psychiatric Institute:
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Obsessive compulsive disorder |
Additional relevant MeSH terms:
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Compulsive Personality Disorder Obsessive-Compulsive Disorder Personality Disorders Mental Disorders Anxiety Disorders Minocycline Serotonin Uptake Inhibitors Anti-Bacterial Agents |
Anti-Infective Agents Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs |