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Completed

NCT Number: NCT01695291

Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD

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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

8 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York State Psychiatric Institute, New York, United States

Loading trial locations.

About this study

Please see the brief summary for study description.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minocycline

Drug

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 names: Minomycin, Minocin, Arestin, Aknemin, Solodyn and Dynacin

Placebo

Other

A placebo pill will be administered twice a day (BID) for 12 weeks.

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale, Child Version (CYBOCS)

    Time frame: Change from Baseline at 4, 8, and 12 weeks

    The Yale-Brown Obsessive Compulsive Scale, Child Version (CYBOCS) is a semi-structured measure of Obsessive-Compulsive Disorder (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. The total CYBOCS score ranges from 0 to 40, with higher scores indicating more severe symptomatology.

Secondary outcomes

  1. Striatal Glutamate Level Measured by Magnetic Resonance Spectroscopy (MRS).

    Time frame: Change from Baseline at 12 weeks

    The change in striatal glutamate level will be assessed.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Weill Medical College of Cornell University

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Sep 27, 2012
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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