Riluzole Augmentation Pilot in Depression (RAPID) Trial

This study is currently recruiting participants.
Verified July 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
David John Wolfe, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01703039
First received: October 4, 2012
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Riluzole
Drug: Sertraline
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Riluzole Augmentation Pilot in Depression (RAPID) Trial

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Mean change in Hamilton Depression Rating Scale (HDRS) 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 HDRS) at endpoint of 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients experiencing remission from depression (HDRS<7) at endpoint of 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in Hamilton Anxiety Rating Scale (HARS) score from baseline to endpoint at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Mean change in Clinical Global Impression (CGI) scale from baseline to endpoint at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: January 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sertraline + riluzole
sertraline 100 mg po daily and riluzole 50 mg po bid
Drug: Riluzole
Other Name: Rilutek
Drug: Sertraline
Other Name: Zoloft
Active Comparator: sertraline + placebo
sertraline 100 mg po daily and placebo
Drug: Sertraline
Other Name: Zoloft
Other: placebo

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703039

Contacts
Contact: David J Wolfe, MD 617-525-8806 DWOLFE@PARTNERS.ORG

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sutanuka Lahiri, MS       SLAHIRI@PARTNERS.ORG   
Contact: David Wolfe, MD       DWOLFE@PARTNERS.ORG   
Principal Investigator: David J Wolfe, MD, MPH         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: David J Wolfe, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: David John Wolfe, Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01703039     History of Changes
Other Study ID Numbers: 2012P001841
Study First Received: October 4, 2012
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Major Depression
Major Depressive Disorder
Depression
Riluzole
Glutamate
Sertraline

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Riluzole
Sertraline
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on April 23, 2014