NCT01703039.

Study name	Riluzole augmentation pilot in depression (RAPID) trial
Methods	Allocation: randomised Endpoint classification: efficacy study Intervention model: parallel assignment Masking: double‐blind (participant, investigator, outcomes assessor) Primary purpose: treatment
Participants	Inclusion criteria Adults (ages 18‐75) who meet DSM‐IV criteria for a major depressive episode HRSD > 22 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 > 5.0 mlU/L), or Abnormal liver function tests (ALT > 50 U/L or AST > 50 U/L) Disallowed therapies include: other psychotropic medications, including antipsychotics, mood stabilisers, benzodiazepines, barbiturates, other sedative‐hypnotics, chronic opiates, or additional antidepressants, psychotherapy, electroconvulsive therapy, vagal nerve stimulations therapy, transcranial magnetic stimulation therapy, or phototherapy
Interventions	Sertraline + riluzole versus placebo
Outcomes	Primary outcome measures: mean change in HRSD score from baseline to endpoint at 8 weeks. Time frame: 8 weeks. [Designated as safety issue: yes] Proportion of patients experiencing an antidepressant response (> 50% reduction in HRSD) at endpoint of 8 weeks. Time frame: 8 weeks. [Designated as safety issue: no] Proportion of patients experiencing remission from depression (HRSD < 7) at endpoint of 8 weeks. Time frame: 8 weeks. [Designated as safety issue: no]
Starting date	January 2013
Contact information	mailto:DWOLFE%40PARTNERS.ORG?subject=NCT01703039, 2012P001841, Riluzole Augmentation Pilot in Depression (RAPID) Trial
Notes	NCT01703039