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:
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
  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 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
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:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality 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 July 23, 2014