Riluzole Augmentation Pilot in Depression (RAPID) Trial
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The investigators are doing a research study to find out if riluzole, when taken along with a standard antidepressant (sertraline) can help people with major depression.
This research study will compare riluzole + sertraline to placebo + sertraline. The investigators hypothesize that adding riluzole will lead to a better antidepressant response, in less time, then sertraline alone.
Full description
Recent attention has focused on the glutamatergic system as a new, distinct target for depression treatment. Riluzole (Rilutek, Sanofi), an oral modulator of glutamate activity with neuroprotective and anticonvulsant properties, is currently approved by the United States Food and Drug Administration for treatment of amyotrophic lateral sclerosis (ALS). Preliminary studies using riluzole to treat depression in humans are promising, though larger, double-blinded controlled trials are needed.
Overall study population:
Adult outpatients with a current, untreated major depressive episode.
Disallowed therapies include: other psychotropic medications, including antipsychotics, mood stabilizers, benzodiazepines, barbiturates, other sedative-hypnotics, chronic opiates, or additional antidepressants, psychotherapy, electroconvulsive therapy, vagal nerve stimulations therapy, transcranial magnetic stimulation therapy, or phototherapy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Adults (ages 18-75) who meet DSM-IV criteria for a major depressive episode,
- Hamilton Depression Rating Scale (HDRS) >22, and
- No antidepressant treatment for at least three weeks
Exclusion criteria
- Active drug or alcohol disorder in the past 3 months
- History of psychosis, history of mania or hypomania
- Epilepsy or history of seizures
- Hypothyroidism
- Congenital QTc prolongation
- Liver disease
- Lung disease
- Acute suicide or homicide risk
- Pregnant women, breastfeeding women, women of childbearing age not using contraception
- Unstable medical illness
- Elevated thyroid-stimulating hormone (TSH>5.0mlU/L), or
- Abnormal liver function tests (ALT>50 U/L or AST>50 U/L)
- ADD / ADHD (Attention deficit hyperactivity disorder)
Disallowed therapies include: other psychotropic medications, including antipsychotics, mood stabilizers, benzodiazepines, barbiturates, other sedative-hypnotics, chronic opiates, or additional antidepressants, psychotherapy, electroconvulsive therapy, vagal nerve stimulations therapy, transcranial magnetic stimulation therapy, or phototherapy.
Trial design
Primary purpose
Allocation
Interventional model
Masking
21 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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