Childhood Obsessive-Compulsive DisorderNCT01019967
A Magnetic Resonance Spectroscopic Examination of Children and Adolescents Taking Riluzole for Obsessive-Compulsive Disorder
An observational study of Childhood Obsessive-Compulsive Disorder and Autism Spectrum Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Obsessive-compulsive disorder (OCD) is a common childhood disorder that often does not respond to standard treatments. Researchers are exploring the role that a brain chemical called glutamate plays in symptoms of OCD, and are testing a drug called riluzole that reduces glutamate to see if changing the… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Childhood Obsessive-Compulsive Disorder, Autism Spectrum Disorders
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2009to 20 Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects may be included in the study only if they meet all of the following criteria:
- Male or female subjects, 7 to 17 years of age.
- Female subjects of childbearing potential must be using a medically accepted means of contraception or must remain abstinent.
- Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study. Each legal guardian must consent to study protocol.
- Subjects must fulfill DSM-IV criteria for (OCD) and have a CY-BOCS score of greater than 20. In the double-blind phase, subjects enrolled in the combined OCD and ASD cohort must also meet DSM-IV criteria for Pervasive Developmental Disorder as well as OCD.
- Each subject already taking medicine must be taking usually effective doses of a medicine demonstrated to be effective in childhood OCD, must have been stable on that dose for at least six weeks, and must have no newly recognized or intolerable adverse effects from that medicine. Subjects who are currently not taking such a medication must have had adequate trial in the past of at least one medicine that has been shown to be effective for the symptoms of childhood OCD, and must have failed to see improvement or must have had intolerable adverse effects from the medicine.
- Subjects must be able to swallow capsules.
- Subject in this protocol will all be enrolled in the riluzole for childhood OCD protocol (NIH 05-M-0225).
Who cannot join
- Subjects will be excluded from the study for any of the following reasons:
- Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, other psychotic disorder, or other serious unstable psychiatric illness. Medicially unstable due to binging, purging, or starvation.
- Judged clinically to be at risk for suicide (suicidal ideation, severe depression, or other factors). Diagnosis of DSM-IV Major Depressive Disorder is not necessarily an exclusion criterion.
- Disabling Tic Disorder requiring contraindicated medicines.
- Female subjects who are pregnant, nursing, or unwilling to use effective contraception.
- Serious unstable illnesses, including gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
Show all 12Show fewer
- Renal or hepatic dysfunction that would interfere with excretion or metabolism of riluzole as evidenced by increase above upper limits of normal for BUN/creatinine, or more than two-fold elevation above upper limits of normal of serum transaminases (ALT/SGPT, AST/SGOT), gamma glutamate (GGT), or bilirubin.
- Documented history of hypersensitivity or intolerance to riluzole.
- DSM-IV Substance Abuse Disorder within the past 90 days or Substance Dependence Disorder within the past 5 years, or any use of tobacco.
- Taking contraindicated drugs.
- Unable to swallow capsules.
- In addition, patients will not receive cognitive-behavior therapy during the period of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Obsessive-compulsive disorder (OCD) is a common childhood disorder that often does not respond to standard treatments. Researchers are exploring the role that a brain chemical called glutamate plays in symptoms of OCD, and are testing a drug called riluzole that reduces glutamate to see if changing the levels of glutamate in the brain will help treat the disorder.
- Researchers are interested in using magnetic resonance spectroscopy (MRS), a type of magnetic imaging, to take pictures of various chemicals in the brain. MRS images will be used to detect changes in brain levels of glutamate in children taking riluzole.
Read more
Objectives:
- To use magnetic resonance spectroscopy to study the levels of glutamate in the brains of children and adolescents who have been taking riluzole.
Eligibility:
- Children and adolescents ages 7 to 17 who are enrolled in the current NIMH riluzole trial protocol (05-M-0225), who are able to lie still in the scanner for about an hour each time, and who are willing to have up to three MRS scans.
Design:
- Researchers will study some children/adolescents before they begin to take the study medication riluzole or placebo these children will have an MRS scan before starting the study medication. The scan will take about an hour.
- About 2 weeks after reaching the full dose on the study medication, participants will have a second hour-long MRS scan. Participants will have a third MRS scan after being on the study medication for 12 weeks.
- Some children who have already completed 12 weeks on riluzole or placebo, and are now taking riluzole, will have only one MRS scan.
Read the detailed description
Objective
This study uses magnetic resonance spectroscopy (MRS) to measure the neurotransmitter glutamate in the anterior cingulate cortex (and, if tolerated, the left caudate nucleus and possibly the thalamus) in children and adolescents.
Study Population
All of the subjects will be participants in an ongoing double-blind placebo-controlled trial (05-M-0225) of a glutamate antagonist, the drug riluzole, for Obsessive-Compulsive Disorder (OCD). The subjects are male and female children and adolescents, ages 7-17 years. They will all have met criteria for clinically significant OCD and will have failed to benefit from standard-of-care treatments or have been unable to tolerate the treatments. Some of the subjects will also have a diagnosis on the autism spectrum.
Design
In one group of sixteen young people, glutamate will be measured in the anterior cingulate cortex at three points in time:
- at baseline, before starting riluzole or placebo;
- within ten to fourteen days of the baseline evaluation, after reaching full dose of the study drug (active drug or placebo) to which the sixteen subjects have just been randomized;
- at the end of the twelve weeks of the double-blind phase of the study.
In a second group of sixteen young people, all of whom are subjects in the open-label phase of the same study, glutamate will be measured (first) in the anterior cingulate cortex at a single point in time when each subject has achieved steady state on the open-label drug riluzole. If the subject tolerates additional time in the scanner, glutamate will also be measured in the left caudate and possibly in the left thalamus. Glutamate levels in this group will be correlated with change in OCD measures.
Outcome Measures
- In the first group, change in glutamate activity in anterior cingulate associated with active drug (riluzole) administration, as compared with change in glutamate activity for the subjects taking placebo.
- In the second group, correlation between serum riluzole level, glutamate activity (or flux) in anterior cingulate (and possibly in the caudate and thalamus), and therapeutic effect.
- Keywords
- Children and Adolescents, Obsessive-Compulsive Disorder, Magnetic Resonance Spectroscopy, Autism, OCD, Obsessive Compulsive Disorder
- Medical subject headings
- Autism Spectrum Disorder, Obsessive-Compulsive Disorder, Autistic Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain glutamate after adding riluzole vs. placebo
Secondary outcomes (1)
Correlation between brain glutamate activity and riluzole level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study start17 Nov 2009
- Study completion20 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Childhood Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan E Swedo, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019967
- Sponsor's protocol ID
- 100024
- Other IDs
- 10-M-0024
- Status last verified
- 20 Sep 2012
- First submitted
- 24 Nov 2009
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Ajroud-Driss S, Saeed M, Khan H, Siddique N, Hung WY, Sufit R, Heller S, Armstrong J, Casey P, Siddique T, Lukas TJ. Riluzole metabolism and CYP1A1/2 polymorphisms in patients with ALS. Amyotroph Lateral Scler. 2007 Oct;8(5):305-9. doi: 10.1080/17482960701500650.
PubMed 17852022Arnold PD, Macmaster FP, Richter MA, Hanna GL, Sicard T, Burroughs E, Mirza Y, Easter PC, Rose M, Kennedy JL, Rosenberg DR. Glutamate receptor gene (GRIN2B) associated with reduced anterior cingulate glutamatergic concentration in pediatric obsessive-compulsive disorder. Psychiatry Res. 2009 May 15;172(2):136-9. doi: 10.1016/j.pscychresns.2009.02.005. Epub 2009 Mar 25.
PubMed 19324536Becquet D, Faudon M, Hery F. In vivo evidence for an inhibitory glutamatergic control of serotonin release in the cat caudate nucleus: involvement of GABA neurons. Brain Res. 1990 Jun 11;519(1-2):82-8. doi: 10.1016/0006-8993(90)90063-h.
PubMed 1975768
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Magnetic Resonance Spectroscopic Examination of Children and Adolescents Taking Riluzole for Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT01019967
- Acronym / sponsor ID
- 100024
- Keywords
- Children and Adolescents, Obsessive-Compulsive Disorder, Magnetic Resonance Spectroscopy, Autism, OCD, Obsessive Compulsive Disorder
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 17 Nov 2009
- Study completion
- 20 Sep 2012
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Obsessive-compulsive disorder (OCD) is a common childhood disorder that often does not respond to standard treatments. Researchers are exploring the role that a brain chemical called glutamate plays in symptoms of OCD, and are testing a drug called riluzole that reduces glutamate to see if changing the levels of glutamate in the brain will help treat the disorder.
- Researchers are interested in using magnetic resonance spectroscopy (MRS), a type of magnetic imaging, to take pictures of various chemicals in the brain. MRS images will be used to detect changes in brain levels of glutamate in children taking riluzole.
Objectives:
- To use magnetic resonance spectroscopy to study the levels of glutamate in the brains of children and adolescents who have been taking riluzole.
Eligibility:
- Children and adolescents ages 7 to 17 who are enrolled in the current NIMH riluzole trial protocol (05-M-0225), who are able to lie still in the scanner for about an hour each time, and who are willing to have up to three MRS scans.
Design:
- Researchers will study some children/adolescents before they begin to take the study medication riluzole or placebo these children will have an MRS scan before starting the study medication. The scan will take about an hour.
- About 2 weeks after reaching the full dose on the study medication, participants will have a second hour-long MRS scan. Participants will have a third MRS scan after being on the study medication for 12 weeks.
- Some children who have already completed 12 weeks on riluzole or placebo, and are now taking riluzole, will have only one MRS scan.
Detailed description
Objective
This study uses magnetic resonance spectroscopy (MRS) to measure the neurotransmitter glutamate in the anterior cingulate cortex (and, if tolerated, the left caudate nucleus and possibly the thalamus) in children and adolescents.
Study Population
All of the subjects will be participants in an ongoing double-blind placebo-controlled trial (05-M-0225) of a glutamate antagonist, the drug riluzole, for Obsessive-Compulsive Disorder (OCD). The subjects are male and female children and adolescents, ages 7-17 years. They will all have met criteria for clinically significant OCD and will have failed to benefit from standard-of-care treatments or have been unable to tolerate the treatments. Some of the subjects will also have a diagnosis on the autism spectrum.
Design
In one group of sixteen young people, glutamate will be measured in the anterior cingulate cortex at three points in time:
- at baseline, before starting riluzole or placebo;
- within ten to fourteen days of the baseline evaluation, after reaching full dose of the study drug (active drug or placebo) to which the sixteen subjects have just been randomized;
- at the end of the twelve weeks of the double-blind phase of the study.
In a second group of sixteen young people, all of whom are subjects in the open-label phase of the same study, glutamate will be measured (first) in the anterior cingulate cortex at a single point in time when each subject has achieved steady state on the open-label drug riluzole. If the subject tolerates additional time in the scanner, glutamate will also be measured in the left caudate and possibly in the left thalamus. Glutamate levels in this group will be correlated with change in OCD measures.
Outcome Measures
- In the first group, change in glutamate activity in anterior cingulate associated with active drug (riluzole) administration, as compared with change in glutamate activity for the subjects taking placebo.
- In the second group, correlation between serum riluzole level, glutamate activity (or flux) in anterior cingulate (and possibly in the caudate and thalamus), and therapeutic effect.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female subjects, 7 to 17 years of age.
- Female subjects of childbearing potential must be using a medically accepted means of contraception or must remain abstinent.
- Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study. Each legal guardian must consent to study protocol.
- Subjects must fulfill DSM-IV criteria for (OCD) and have a CY-BOCS score of greater than 20. In the double-blind phase, subjects enrolled in the combined OCD and ASD cohort must also meet DSM-IV criteria for Pervasive Developmental Disorder as well as OCD.
- Each subject already taking medicine must be taking usually effective doses of a medicine demonstrated to be effective in childhood OCD, must have been stable on that dose for at least six weeks, and must have no newly recognized or intolerable adverse effects from that medicine. Subjects who are currently not taking such a medication must have had adequate trial in the past of at least one medicine that has been shown to be effective for the symptoms of childhood OCD, and must have failed to see improvement or must have had intolerable adverse effects from the medicine.
Key exclusion criteria (12 listed)
- Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, other psychotic disorder, or other serious unstable psychiatric illness. Medicially unstable due to binging, purging, or starvation.
- Judged clinically to be at risk for suicide (suicidal ideation, severe depression, or other factors). Diagnosis of DSM-IV Major Depressive Disorder is not necessarily an exclusion criterion.
- Disabling Tic Disorder requiring contraindicated medicines.
- Female subjects who are pregnant, nursing, or unwilling to use effective contraception.
- Serious unstable illnesses, including gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in brain glutamate after adding riluzole vs. placebo
1 secondary outcome
Correlation between brain glutamate activity and riluzole level
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 17852022Ajroud-Driss S, Saeed M, Khan H, Siddique N, Hung WY, Sufit R, Heller S, Armstrong J, Casey P, Siddique T, Lukas TJ. Riluzole metabolism and CYP1A1/2 polymorphisms in patients with ALS. Amyotroph Lateral Scler. 2007 Oct;8(5):305-9. doi: 10.1080/17482960701500650.
- Background: PubMed 19324536Arnold PD, Macmaster FP, Richter MA, Hanna GL, Sicard T, Burroughs E, Mirza Y, Easter PC, Rose M, Kennedy JL, Rosenberg DR. Glutamate receptor gene (GRIN2B) associated with reduced anterior cingulate glutamatergic concentration in pediatric obsessive-compulsive disorder. Psychiatry Res. 2009 May 15;172(2):136-9. doi: 10.1016/j.pscychresns.2009.02.005. Epub 2009 Mar 25.
- Background: PubMed 1975768Becquet D, Faudon M, Hery F. In vivo evidence for an inhibitory glutamatergic control of serotonin release in the cat caudate nucleus: involvement of GABA neurons. Brain Res. 1990 Jun 11;519(1-2):82-8. doi: 10.1016/0006-8993(90)90063-h.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E Swedo, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obsessive-Compulsive Disorder and Autism Spectrum Disorders, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain glutamate after adding riluzole vs. placebo. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01019967, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.