Riluzole Augmentation Pilot in Depression (RAPID) Trial

• Status: Terminated
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Riluzole; Sertraline

Criteria

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.