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 weeksProportion 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 weeksMean 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
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