This study examines if Riluzole, FDA approved for ALS, will improve symptoms of depression in
Bipolar Disorder.
Purpose: This study will examine the safety and effectiveness of riluzole (Rilutek trademark)
for short-term treatment of depression symptoms, such as depressed mood, psychomotor
retardation, and excessive sleeping in patients with bipolar disease. Riluzole is approved by
the Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS, also
known as Lou Gehrig's disease). Preliminary findings of a study using riluzole to treat acute
depression in patients with unipolar depression indicate that it may have antidepressant
properties in some patients.
Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may
be eligible for this 8-week study. Candidates must be currently depressed, must have had at
least one previous major depressive episode, and must have failed to improve with prior
treatment with at least one antidepressant. They will be screened with a medical history,
physical examination, electrocardiogram (EKG), blood and urine tests, and psychiatric
evaluation. A blood or urine sample will be analyzed for illegal drugs. Women of childbearing
potential will have a pregnancy test.
Participants will begin an 8-week course of treatment, starting with a placebo (a sugar pill
formulated to look like the active drug) and, at some point, switching to riluzole. In
addition to drug treatment, participants will undergo the following procedures:
Physical examination and electrocardiogram (EKG) at the beginning and end of the study;
Weekly check of vital signs (temperature, blood pressure and heart rate);
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.
Atendemos pacientes de habla hispana.
We enroll eligible participants locally and from around the country. Travel arrangements are
provided and costs covered by the National Institute of Mental Health (NIMH). (Arrangements
vary by distance and by specific study.) After completing the study participants receive
short-term follow-up care while transitioning back to a provider.