Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Minocycline; Placebo
Intervention description: 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.; A placebo pill will be administered twice a day (BID) for 12 weeks.
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 8 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Obsessive compulsive disorder

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 magnetic resonance
      spectroscopy (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 the New York State Psychiatric Institute (NYSPI) and
      the MRS scans may be conducted at Weill Cornell Medical Center or NYSPI.
    

Eligibility 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

          -  Intelligence quotient (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