Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2014 by New York State Psychiatric Institute

Sponsor:

Collaborators:

National Institute of Mental Health (NIMH)

Weill Medical College of Cornell University

Information provided by (Responsible Party):

New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT01695291

First received: September 21, 2012

Last updated: April 2, 2014

Last verified: April 2014

History of Changes

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:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

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

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 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 19 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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695291

Contacts


Contact: Moira Rynn, M.D.	(646) 774-5805	RynnM@nyspi.columbia.edu
Contact: Prerna Martin, MPH	(646) 774-5793	pmartin@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. 646-774-5805 RynnM@nyspi.columbia.edu
Contact: Prerna Martin, MPH (646) 774-5793 pmartin@nyspi.columbia.edu
Principal Investigator: Moira Rynn, M.D.
Sub-Investigator: Helen Blair Simpson, M.D.
Sub-Investigator: Lawrence Kegeles, 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

National Institute of Mental Health (NIMH)

Weill Medical College of Cornell University

Investigators


Principal Investigator:	Moira A Rynn, MD	Columbia University/NYSPI

More Information

No publications provided


Responsible Party:	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 2, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:


Obsessive compulsive disorder

Additional relevant MeSH terms:


Compulsive Personality Disorder Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Personality Disorders	Minocycline Anti-Bacterial Agents Anti-Infective Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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