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Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD

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

NCT01695291•New York State Psychiatric Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

8 - 20 years

Sex

ALL

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)
+4 more criteria

Locations (2)

Weill Cornell Medical Center

New York, New York, United States

New York State Psychiatric Institute

New York, New York, United States

Key Dates

Start Date

May 1, 2012

Primary Completion Date

May 1, 2017

Completion Date

May 1, 2018

Last Updated

November 13, 2019

Enrollment

ACTUAL participants

Conditions

Obsessive Compulsive Disorder

Interventions

Minocycline

DRUG

Placebo

OTHER

Precision Analytic Research Methods in OCD

NCT07011901

Obsessive Compulsive Disorder

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RECRUITING

Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation

NCT06763081

Behavioral ActivationMajor Depressive Disorder+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD

Inclusion Criteria

Exclusion Criteria

Precision Analytic Research Methods in OCD

Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation

Brief Cognitive Behaviour Therapy (CBT) for Adolescent OCD in Routine Clinical Practice

Combined Cortical/Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorder

NAC for Treatment-Resistant OCD and Other Related Disorders

Assessments of Obsessive-compulsive Symptoms in Patients With Substances Use Disorder