Riluzole Augmentation Pilot in Depression (RAPID) Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2018 |
| Start Date: | January 2013 |
| End Date: | September 2019 |
| Contact: | Molly O'Reilly, MA |
| Email: | RAPID@PARTNERS.ORG |
| Phone: | 617-525-8443 |
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.
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.
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.
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.
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.
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: David J Wolfe, MD, MPH
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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