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Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Minocycline
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive compulsive disorder

Eligibility Criteria

8 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medical Center
  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Minocycline Augmentation

Arm Description

Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.

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.

Outcomes

Primary Outcome Measures

Yale-Brown Obsessive Compulsive Scale, Child Version (CYBOCS)
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 Outcome Measures

Striatal Glutamate Level Measured by Magnetic Resonance Spectroscopy (MRS).
The change in striatal glutamate level will be assessed.

Full Information

First Posted
September 21, 2012
Last Updated
October 30, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH), Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01695291
Brief Title
Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
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 Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH), Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
Detailed Description
Please see the brief summary for study description.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Obsessive compulsive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to placebo will receive pills that are identical in appearance to the study drug but contain no active medication.
Arm Title
Minocycline Augmentation
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Minocycline
Other Intervention Name(s)
Minomycin, Minocin, Arestin, Aknemin, Solodyn and Dynacin
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A placebo pill will be administered twice a day (BID) for 12 weeks.
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale, Child Version (CYBOCS)
Description
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.
Time Frame
Change from Baseline at 4, 8, and 12 weeks
Secondary Outcome Measure Information:
Title
Striatal Glutamate Level Measured by Magnetic Resonance Spectroscopy (MRS).
Description
The change in striatal glutamate level will be assessed.
Time Frame
Change from Baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moira A Rynn, M.D.
Organizational Affiliation
Columbia University/NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD

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