Riluzole Augmentation Pilot in Depression (RAPID) Trial

NCT01703039 | Terminated Phase 2 Results DMC

• 1 other identifier: 2012P001841
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major Depression; Major Depressive Disorder; Depression; Riluzole; Glutamate; Sertraline

Outcome Measures

Primary Outcomes (3)

• Mean Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks

  The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52.

  0 weeks-8 weeks

• Number of Patients Experiencing an Antidepressant Response (>50% Reduction in HDRS) at Endpoint of 8 Weeks

  The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52.

  0 weeks-8 weeks

• Number of Patients Experiencing Remission From Depression (HDRS<7) at Endpoint of 8 Weeks

  The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52.

  0 weeks-8 weeks

Secondary Outcomes (2)

• Mean Change in Hamilton Anxiety Rating Scale (HARS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks

  0 weeks-8 weeks

• Mean Change in Clinical Global Impression (CGI) Scale From Baseline (0 Weeks) to Endpoint at 8 Weeks

  0 weeks-8 weeks

Study Arms (2)

sertraline + riluzole

EXPERIMENTAL

sertraline 100 mg po daily and riluzole 50 mg po bid

Drug: Riluzole; Drug: Sertraline

sertraline + placebo

ACTIVE COMPARATOR

sertraline 100 mg po daily and placebo

Drug: Sertraline; Other: placebo

Interventions

Riluzole DRUG

Also known as: Rilutek

sertraline + riluzole

Sertraline DRUG

Also known as: Zoloft

sertraline + placebo; sertraline + riluzole

placebo OTHER

sertraline + placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Riluzole; Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 1-Naphthylamine; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Jessica Harder
• Organization: Brigham and Women's Hospital

jaharder@bwh.harvard.edu

617-525-7919

Study Officials

• Jessica Harder, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 10, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Locations

US (1)