Depression Clinical Trial
Official title:
An Investigation of the Antidepressant Efficacy of an Antiglutamatergic Agent With Neurotrophic Properties in Major Depression
This study will examine the safety and effectiveness of the drug riluzole (Rilutek®
(Registered Trademark)) for short-term treatment of depression symptoms, such as depressed
mood, psychomotor retardation, and excessive sleeping. Despite the availability of a wide
range of antidepressant drugs, studies indicate that 30 to 40 percent of patients with major
depression do not respond to first-line antidepressant treatment with drugs such as
fluoxetine, upropion, venlafaxine and others. Riluzole, which is approved by the Food and
Drug Administration (FDA) for amyotrophic lateral sclerosis (ALS), causes chemical changes
in the brain that may also have antidepressant properties.
Patients between 18 and 70 years of age with major depressive disorder without psychotic
features may be eligible for this 2-stage 7-week study. Candidates will be screened with a
medical history and physical examination, including an electrocardiogram (EKG), blood and
urine tests, and a psychiatric evaluation. A
blood or urine sample will be tested for illegal drugs.Women of childbearing potential will
have a pregnancy test.
Participants will complete stage 1 of the study, which lasts 1 week, and may then continue
with stage 2 for an additional 6 weeks. At the start of the study, patients will be tapered
off all psychiatric medicines and will begin treatment with a placebo (a sugar pill
formulated to look like the active drug). At some point, they will be switched from placebo
to riluzole. In addition, participants will undergo the following procedures:
- Physical examination and electrocardiograms (EKG) at the beginning and end of the
study, with vital signs (temperature, blood pressure and heart rate) checked daily
- Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to
assess treatment response
- Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects
At the end of the study, participants' psychiatric status will be reassessed and appropriate
long-term psychiatric treatment arranged.
Patients, ages 18 to 70 with a diagnosis of major depression without psychotic features,
will in this pilot study (single arm, single blind) receive riluzole (50-200 mg/day) for a
period of 6 weeks. Acute efficacy will be determined by demonstrating a greater response
rate using specified criteria.
Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6
weeks of acute riluzole treatment. Therefore, if 7/22 patients or greater have greater than
50% improvement on the primary efficacy measure, then based on statistically guidelines from
the Optimal Two Stage Design for Clinical Trials, a controlled trial would be indicated to
scientifically confirm the signal observed in the single arm trial.
Major affective disorders are common, severe, chronic and often life-threatening illnesses.
Major depression contributes to significant morbidity and mortality. Impairment in physical
and social functioning resulting from depression can be just as severe as other chronic
medical illnesses. Suicide is the cause of death in 10-20% of individuals with either
bipolar or recurrent depressive disorders.
Despite the availability of a wide range of antidepressant drugs, clinical trials indicate
that 30% to 40% of patients with major depression fail to respond to first-line
antidepressant treatment, despite adequate dosage, duration, and compliance. Thus, there is
a clear need to develop novel and improved therapeutics for unipolar and bipolar depression.
Recent preclinical studies suggest that antidepressants may exert delayed indirect effects
on the glutamatergic system. Furthermore, a growing body of data suggests that mood
disorders are associated with regional volumetric reductions, and cell loss and atrophy. It
is thus noteworthy that lamotrigine, which, among other effects reduces glutamate release,
has antidepressant effects, and a pilot study has suggested that NMDA antagonists may have
antidepressant effects. Together, this data suggests that the glutamatergic system may play
a role in the pathophysiology and treatment of depression, and that agents, which more
directly reduce glutamatergic neurotransmission, may represent a novel class of
antidepressants.
Riluzole, an agent that is Food and Drug Administration-approved for Amyotrophic Lateral
Sclerosis has significant antiglutamatergic and neuroprotective properties, may prove to
have antidepressant properties in depressed patients. In this study, we propose to
investigate the potential antidepressant efficacy of riluzole, an agent which reduces
glutamatergic throughput via inhibition of its release, which also exerts robus neurotrophic
effects.
This is a 6-week single-arm, single-blind study that will examine the efficacy and safety of
riluzole in patients with major depression without psychotic features.
The study has two Study Periods. Study Period I is the washout phase that will last 7 days.
Study Period II is a monotherapy 6-week acute treatment phase in which the efficacy and
tolerability of riluzole is compared to baseline.
Patients, ages 18 to 60 with a diagnosis of major depression without psychotic features,
will in this pilot study (single arm, single-blind) receive riluzole (50-200 mg/day) for a
period of 6 weeks. Acute efficacy will be determined by demonstrating a greater response
rate using specified criteria.
Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6
weeks of acute riluzole treatment. Therefore if 7/22 patients or greater have greater than
50% improvement on the primary efficacy measure, then based on statistically guidelines from
the Optimal Two Stage Design for Clinical Trials, a controlled trial would be indicated to
scientifically confirm the signal observed in the single arm trial.
;
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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