Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695291
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : July 12, 2018
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Moira A. Rynn, New York State Psychiatric Institute

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

Detailed Description:
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
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

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, Learn About Clinical Studies.

Ages Eligible for Study:   8 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01695291

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
Principal Investigator: Moira A Rynn, M.D. Columbia University/NYSPI

Responsible Party: Moira A. Rynn, Associate Professor of Clinical Psychiatry, New York State Psychiatric Institute 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: July 12, 2018
Last Verified: July 2018

Keywords provided by Moira A. Rynn, New York State Psychiatric Institute:
Obsessive compulsive disorder

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
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