| City: |
|
Bethesda |
|
State:
|
|
MD |
| Zip Code: |
|
20892 |
| Conditions: |
|
Obsessive-Compulsive Disorder - Autism Spectrum Disorder - Autism - Asperger Disorder - Development Disorder |
| Purpose: |
|
This study will examine the effectiveness of riluzole for treating Obsessive-Compulsive
Disorder in Youth, Including those with Autism Spectrum Disorders.
|
| Study summary: |
|
Obsessive-Compulsive Disorder (OCD) is a chronic psychiatric disorder characterized by the
presence of intrusive and unwanted obsessional thoughts and images and of compulsive
behaviors. Its presentation during childhood is similar to that seen in adulthood, except
that children sometimes lack insight into the senselessness of the thoughts and behaviors.
Although many patients benefit from treatment with selective serotonin reuptake inhibitors
(SSRIs), a significant proportion have limited or no response to these medications.
Additionally, these medicines have been associated with a slight but significant increase in
onset of suicidal thoughts among adolescents being treated for depression or OCD. Cognitive
behavioral therapy (CBT) may also be effective for OCD, alone or in combination with SSRIs,
but there is a shortage of qualified therapists, and many patients and families cannot
participate effectively in the therapy. Further, in a recent report on a multi-site study
of childhood OCD, CBT alone at one site fared little better than placebo.
There is a pressing need, then, for the development of alternative, novel treatments for
pediatric OCD. Neuropsychological and neuroimaging data suggest that OCD may arise from
dysfunction of orbitofronto-striato-thalamocortical circuitry. Glutamate plays a crucial
role in the regulation of excitatory activity within this circuit and may be involved in the
etiopathogenesis of OCD. If so, then agents which reduce glutamatergic neurotransmission
may provide unique antiobsessional benefits. Riluzole is a medication that reduces
glutamatergic activity. It is currently being studied in adults with OCD, and this
two-stage study will evaluate the possibility that riluzole will help children with OCD,
Riluzole has been approved by the Food and Drug Administration (FDA) for treatment of
amyotrophic lateral sclerosis (ALS), and is currently under investigation at the NIMH for
treatment of depression.
The first stage of this investigation has been completed. Six children with OCD, ages 7 to
17 years, received riluzole as part of a study that evaluated the drug's safety and
estimated the appropriate dose of riluzole Riluzole was added to the children's current
medication regimen or was used as sole agent. The second stage of the investigation will
enroll up to 60 additional subjects with OCD including some who have both autistic spectrum
disorder (ASD) and OCD. The subjects will participate in a double-blind,
placebo-controlled12-week trial of riluzole as a sole agent or as an augmentation to their
currently inadequate therapy. Following the double-blind portion of the trial, subjects may
receive three months of open-label treatment with riluzole, if it is clinically indicated.
All subjects will be followed at regular intervals until one year from baseline. |
| Criteria: |
|
- INCLUSION CRITERIA:
Subjects may be included in the study only if they meet all of the following criteria:
1. Male or female subjects, 7 to 17 years of age.
2. Male and female subjects of childbearing potential must be using a medically accepted
means of contraception or must remain abstinent.
3. 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.
4. 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.
5. 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.
6. Subjects must be able to swallow capsules.
EXCLUSION CRITERIA:
Subjects will be excluded from the study for any of the following reasons:
1. Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar
disorder, other psychotic disorder, or other serious unstable psychiatric illness.
Medically unstable due to binging, purging, or starvation.
2. 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.
3. Disabling Tic Disorder requiring contraindicated medicines.
4. Male or female subjects who are unwilling to use effective contraception, or female
subjects who are pregnant or nursing.
5. Serious unstable illnesses, including gastroenterologic, respiratory, cardiovascular
(including ischemic heart disease), endocrinologic, neurologic, immunologic, or
hematologic disease.
6. 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.
7. Documented history of hypersensitivity or intolerance to riluzole.
8. DSM-IV Substance Abuse Disorder within the past 90 days or Substance Dependence
Disorder within the past 5 years, or any use of tobacco.
9. Taking contraindicated drugs.
10. Unable to swallow capsules.
11. In addition, patients will not receive cognitive-behavior therapy during the period
of the study. |
|
|
|
| Study is available at: |
|
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 21, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|