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Efficacy and Tolerability of Riluzole in Treatment Resistant Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Tolerability of Riluzole in Treatment Resistant Depression

NCT01204918•Yale University

Summary

This study aims to examine the antidepressant efficacy of riluzole, employing a randomized, double-blind, placebo-controlled, adjunctive trial in treatment-resistant major depressive disorder (TRD).

Detailed Description

This study aims to examine the antidepressant efficacy of riluzole, employing a randomized, double-blind, placebo-controlled, 8 week trial of adjunctive trial in treatment-resistant major depressive disorder (TRD). Preclinical studies have shown riluzole to modulate Glu release and clearance, and to have potent neuroprotective properties, promoting neuro-resiliency. Other preclinical data now also show the drug to have antidepressant-like effects in rodent models used to screen for antidepressant activity. In addition, several small open-label clinical studies further suggest riluzole has antidepressant and anxiolytic properties, even in patients who do not respond to standard monoaminergic antidepressant and anxiolytic medications.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Group A inclusion/exclusion
•1. Age 18-65
•2. Written informed consent
•3. Meets DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for MDD, current
•4. Inventory of Depressive Symptomatology - Self-Rated (IDS-SR30) score of \> 20 at screening, baseline and start of double-blind phase (Phase 2)
•5. May have a history of failure to respond to up to two FDA-approved antidepressants at adequate doses during the current episode for at least 8 weeks, and for inclusion into the Phase 2 subjects must have failed the 8-week prospective citalopram treatment.
•6. Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher at baseline and start of Phase 2.
•1. Age 18-65
•2. Written informed consent
•3. Meets DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for MDD, current
+3 more criteria

Exclusion Criteria

•1. Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
•2. Patients who no longer meet DSM-IV criteria for MDD during the baseline visit
•3. Patients who demonstrate \> 50% decrease in depressive symptoms as reflected by the IDS-SR total score from screen to baseline
•4. Serious suicide or homicide risk, as assessed by evaluating clinician A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
•5. Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
•6. The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past)
•7. History of a seizure disorder or clinical evidence of untreated hypothyroidism
•8. Patients requiring excluded medications (see Table 3 for details)
•9. Psychotic features in the current episode or a history of psychotic features, as assessed by SCID
•10. Any investigational psychotropic drug within the last 3 months
+22 more criteria

Locations (3)

Yale University, Yale Depression Research Program

New Haven, Connecticut, United States

Massachussettes General Hospital, Depression Clinical and Research Center

Boston, Massachusetts, United States

Baylor College of Medicine

Houston, Texas, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

May 1, 2015

Completion Date

August 1, 2015

Last Updated

March 6, 2020

Enrollment

104

ACTUAL participants

Conditions

Depression

Interventions

Riluzole

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Tolerability of Riluzole in Treatment Resistant Depression

Inclusion Criteria

Exclusion Criteria

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