Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD

NCT ID: NCT01695291

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2018-05-31

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.

Conditions

Obsessive Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Minocycline Augmentation

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.

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Minomycin, Minocin, Arestin, Aknemin, Solodyn and Dynacin

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Helen Blair Simpson

Research Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moira A Rynn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University/NYSPI

Locations

Weill Cornell Medical Center

New York, New York, United States

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R34MH095502-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6574

Identifier Type: -

Identifier Source: org_study_id