Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 8 - 20 |
| Updated: | 3/15/2019 |
| Start Date: | May 2012 |
| End Date: | January 2018 |
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
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.
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.
Please see the brief summary for study description.
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
We found this trial at
2
sites
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Principal Investigator: Moira Rynn, M.D.
Phone: 646-774-5805
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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