Please select the outcome measures that correspond to the clinical trial below.
Title: An Investigation of the Antidepressant Efficacy of an Antiglutamatergic Agent in Bipolar Depression
Brief Summary: 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.


Options:
A: Level of Depression as assessed by the HAM-D (Day 1-7)
B: Composite blood based biomarker (5 years)
C: Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 0 to week 8 of the study); Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 9 to week 16 of the study); Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 0 to week 8 of the study); Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Received drug for 8 weeks during week 9 to week 16 of the study)
D: Montgomery-Asberg Depression Rating Scale (8 weeks)

Answer: D