Clinical trial NCT01703039: Riluzole Augmentation Pilot in Depression (RAPID) Trial
Official title: Riluzole Augmentation Pilot in Depression (RAPID) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depression
Major Depressive Disorder
Depression
Riluzole
Glutamate
Sertraline
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks
timeFrame: 0 weeks-8 weeks
measure: Number of Patients Experiencing an Antidepressant Response (>50% Reduction in HDRS) at Endpoint of 8 Weeks
timeFrame: 0 weeks-8 weeks
measure: Number of Patients Experiencing Remission From Depression (HDRS<7) at Endpoint of 8 Weeks
timeFrame: 0 weeks-8 weeks
Secondary outcomes:
measure: Mean Change in Hamilton Anxiety Rating Scale (HARS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks
timeFrame: 0 weeks-8 weeks
measure: Mean Change in Clinical Global Impression (CGI) Scale From Baseline (0 Weeks) to Endpoint at 8 Weeks
timeFrame: 0 weeks-8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jessica Harder, MD
role: PRINCIPAL_INVESTIGATOR
References: