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Major Depressive Disorder | Riluzole Augmentation Pilot in Depression (RAPID) Trial

Major Depressive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Riluzole

Drug:Sertraline

Other:placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

sertraline + riluzolesertraline 100 mg po daily and riluzole 50 mg po bid

sertraline + placebosertraline 100 mg po daily and placebo

Study Status

Recruiting

Start Date: January 2013

Completed Date: September 2019

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Mean change in Hamilton Depression Rating Scale (HDRS) score from baseline to endpoint at 8 weeks

Secondary Outcome: Mean change in Hamilton Anxiety Rating Scale (HARS) score from baseline to endpoint at 8 weeks

Study sponsors, principal investigator, and references

Principal Investigator: David J Wolfe, MD

Lead Sponsor: Brigham and Women's Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01703039

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