Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder
Status: | Completed |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | September 2006 |
End Date: | August 2015 |
A Double-blind Study of Riluzole Augmentation in Serotonin Reuptake Inhibitor-refractory Obsessive-compulsive Disorder and Depression
Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal
of suffering. Many patients benefit from established treatments, the mainstay of which are
cognitive behavioral therapy and a group of antidepressant medications known as serotonin
reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established
therapeutic strategies. New avenues of treatment are urgently needed.
Existing medications for obsessive-compulsive disorder affect the neurotransmitters
serotonin or dopamine; but increasing evidence suggests that functional disruptions of a
different neurotransmitter, glutamate, may contribute to some cases of OCD. The
investigators are therefore interested in using medications that target glutamate as novel
treatment options for those OCD patients who do not benefit from established treatments.
One such medication is the drug riluzole, which is FDA approved for amyotrophic lateral
sclerosis (ALS), or Lou Gehrig's disease, but may be of benefit to patients with psychiatric
disorders due to its ability to moderate excessive glutamate. In preliminary studies, in
which the investigators treated patients with riluzole (in addition to their established
pharmacological regimen) in an open-label fashion (that is, without a placebo-treated
control group), the investigators have found about 40-50% of patients to substantially
improve over 2-3 months.
While immensely promising, these preliminary studies do not prove riluzole is truly a new
beneficial medication for the treatment of OCD; a more rigorous placebo-controlled trial is
needed for that purpose. The investigators are therefore now recruiting patients to
participate in a double-blind, placebo-controlled trial of riluzole, added to whatever other
OCD medications they are taking.
of suffering. Many patients benefit from established treatments, the mainstay of which are
cognitive behavioral therapy and a group of antidepressant medications known as serotonin
reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established
therapeutic strategies. New avenues of treatment are urgently needed.
Existing medications for obsessive-compulsive disorder affect the neurotransmitters
serotonin or dopamine; but increasing evidence suggests that functional disruptions of a
different neurotransmitter, glutamate, may contribute to some cases of OCD. The
investigators are therefore interested in using medications that target glutamate as novel
treatment options for those OCD patients who do not benefit from established treatments.
One such medication is the drug riluzole, which is FDA approved for amyotrophic lateral
sclerosis (ALS), or Lou Gehrig's disease, but may be of benefit to patients with psychiatric
disorders due to its ability to moderate excessive glutamate. In preliminary studies, in
which the investigators treated patients with riluzole (in addition to their established
pharmacological regimen) in an open-label fashion (that is, without a placebo-treated
control group), the investigators have found about 40-50% of patients to substantially
improve over 2-3 months.
While immensely promising, these preliminary studies do not prove riluzole is truly a new
beneficial medication for the treatment of OCD; a more rigorous placebo-controlled trial is
needed for that purpose. The investigators are therefore now recruiting patients to
participate in a double-blind, placebo-controlled trial of riluzole, added to whatever other
OCD medications they are taking.
Inclusion Criteria:
- DSM-IV diagnosis of OCD, confirmed by SCID-IV; symptoms of at least 1 year duration
- moderate to severe OCD symptoms (Y-BOCS > 16)
- documented failure of an adequate trial of an SSRI
- agreement to engage in a reliable form of birth control (women only)
Exclusion Criteria:
- primary diagnosis of a psychotic disorder
- active substance abuse or dependence
- unstable medical condition
- prior exposure to riluzole
- prior psychosurgery
- pregnancy, breastfeeding, or intent to become pregnant during study
- liver function tests (LFTs) elevated to more than 2x the upper limit of normal
- evidence of active liver disease
- seizure disorder
- active suicidal ideation
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