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

September 21, 2012
April 2, 2014
May 2012
May 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01695291 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
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

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.

Please see the brief summary for study description.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Obsessive Compulsive Disorder
  • 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
  • Other: Placebo
    A placebo pill will be administered BID for 12 weeks.
  • Placebo Comparator: Placebo
    Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
    Intervention: Other: Placebo
  • 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.
    Intervention: Drug: Minocycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
8 Years to 20 Years
No
Contact: Moira Rynn, M.D. (646) 774-5805 RynnM@nyspi.columbia.edu
Contact: Prerna Martin, MPH (646) 774-5793 pmartin@nyspi.columbia.edu
United States
 
NCT01695291
6574, R34MH095502-01
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
  • National Institute of Mental Health (NIMH)
  • Weill Medical College of Cornell University
Principal Investigator: Moira A Rynn, MD Columbia University/NYSPI
New York State Psychiatric Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP