Riluzole Augmentation Pilot in Depression (RAPID) Trial

NCT ID: NCT01703039

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-06-30

Brief 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.

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

sertraline + riluzole

sertraline 100 mg po daily and riluzole 50 mg po bid

Group Type: EXPERIMENTAL

Riluzole

Intervention Type: DRUG

Sertraline

Intervention Type: DRUG

sertraline + placebo

sertraline 100 mg po daily and placebo

Group Type: ACTIVE_COMPARATOR

Sertraline

Intervention Type: DRUG

placebo

Intervention Type: OTHER

Interventions

Riluzole

Intervention Type: DRUG

Sertraline

Intervention Type: DRUG

placebo

Intervention Type: OTHER

Other Intervention Names

Rilutek; Zoloft

Eligibility 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)
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jessica Harder

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Harder, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2012P001841

Identifier Type: -

Identifier Source: org_study_id