Riluzole Augmentation Pilot in Depression (RAPID) Trial
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT01703039
- Run by
- Brigham and Women's Hospital
- People needed
- 21
- Starts
- 2013-01-01
- Expected to finish
- 2018-06-01
- Last updated by the study team
- 2019-08-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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