Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD

Obsessive Compulsive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695291
• Other study ID #: 6574
• Secondary ID: R34MH095502-03
• Status: Completed
• Phase: Phase 2
• Start date: May 2012
• Est. completion date: May 2018

Study information

• Verified date: October 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please see the brief summary for study description.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York
United States	Weill Cornell Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH), Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline at 4, 8, and 12 weeks
Secondary	Striatal Glutamate Level Measured by Magnetic Resonance Spectroscopy (MRS).	The change in striatal glutamate level will be assessed.	Change from Baseline at 12 weeks