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Riluzole Augmentation Pilot in Depression (RAPID) Trial

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Riluzole (Drug); Sertraline (Drug); placebo (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
David J Wolfe, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital

Overall contact:
David J Wolfe, MD, Phone: 617-525-8806, Email: DWOLFE@PARTNERS.ORG

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.

Clinical Details

Official title: Riluzole Augmentation Pilot in Depression (RAPID) Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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

Proportion of patients experiencing an antidepressant response (>50% reduction in HDRS) at endpoint of 8 weeks

Proportion of patients experiencing remission from depression (HDRS<7) at endpoint of 8 weeks

Secondary outcome:

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

Mean change in Clinical Global Impression (CGI) scale from baseline to endpoint at 8 weeks

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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)

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.

Locations and Contacts

David J Wolfe, MD, Phone: 617-525-8806, Email: DWOLFE@PARTNERS.ORG

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Jennifer Zinser, Email: jzinser@PARTNERS.ORG
David Wolfe, MD, Email: DWOLFE@PARTNERS.ORG
David J Wolfe, MD, MPH, Principal Investigator
Additional Information

Starting date: January 2013
Last updated: January 26, 2015

Page last updated: August 23, 2015

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