Johns Hopkins Medicine - Department of Psychiatry and Behavioral Sciences

 Mood Disorders Program

Double-Blind Placebo-Controlled Trial of RILUZOLE
in Bipolar Depression      

Bipolar Disorder is a serious, often life-threatening illness that causes a significant amount of suffering and disability.The study protocol calls for 100 participants between the ages of 18 and 75 years of age who are already being treated with a mood stabilizer (lithium, depakote, or tegretol). 

The study will last 8 to 12 weeks and will require weekly visits. Participants will come to The Johns Hopkins Hospital for a screening visit during which they will talk with a psychiatrist, answer questions about their mood and symptoms, have their blood drawn, and have a brief physical exam. If they meet criteria for the study, any antidepressant medication that they are taking will be tapered and stopped. 

All participants will continue on mood stabilizers throughout the study. Participants will then receive either Riluzole or a placebo for the next 8 weeks. A placebo is a sugar pill that is expected to have no effect and participants will have a 50% chance of getting the placebo. Throughout the course of the study, neither the participants nor the researchers will know who is getting which treatment. Participants will meet with the team psychiatrist weekly to check for symptoms and side effects. 

Participation in the study includes free study medication, labs, and testing, plus reimbursement for transportation. Participants will also be paid and after the study referred back to their treating psychiatrist with treatment recommendations.

If you are interested in participating in this study, please call 410-502-2334.

Inclusion Criteria:

• Ages 18-75
• Diagnosed with Bipolar I or II disorder and currently depressed
• Tried at least one antidepressant during the current episode of depression
• Currently taking either lithium, depakote, or tegretol
• Currently in outpatient treatment with a psychiatrist

Exclusion Criteria:

• Current psychotic symptoms
• Women who are pregnant or nursing
• Any serious, uncontrolled medical illness
• History of liver problems
• Current or past blood diseases
• Current drug or alcohol abuse
• Currently receiving Electroconvulsive Shock Therapy (ECT)
• Judged to be at serious suicidal risk

Below, please find the list of forms that you will be completing during the course of the study. Should you misplace a form between visits, you can simply print it out by clicking on the appropriate icon below:

Medication Tracking Form

What is Riluzole?

Riluzole is a medication that is used to treat Lou Gehrig’s Disease.  It is a member of the benzothiazole class of drugs.  Riluzole is thought to act by decreasing the release of a brain chemical called glutamate.  In addition, research studies have demonstrated that Riluzole possesses neuroprotective properties that make it useful in the treatment of Lou Gehrig’s Disease and possibly in the treatment of depression.

What are the benefits of taking Riluzole?

Preliminary studies suggest that it acts as an antidepressant in patients with bipolar depression and major depression by decreasing the release of a brain chemical called glutamate.

Have other clinical trials been conducted on the use of Riluzole in unipolar or bipolar depression?

Two major studies have been conducted at the National Institutes of Health by Zarate and colleagues demonstrating the effectiveness of Riluzole, one in the treatment of unipolar depression and a second in the treatment of bipolar depression.  A full text copy of both articles can be obtained by going to www.pubmed.com and searching for the following citations:

Zarate CA Jr, Payne JL, Quiroz J, Sporn J, Denicoff KK, Luckenbaugh D, Charney DS, Manji HK. (2004, January).  An open-label trial of riluzole in patients with treatment-resistant major depression.  American Journal of Psychiatry, 161 (1), 171 - 174.  

Zarate, CA, Quiroz, JA, Singh, JB, Denicoff, KD, De Jesus, G, Luckenbaugh, DA, Charney, DS, Manji, HK.  (2005).  An open-label trial of the glutamate-modulating agent Riluzole in combination with lithium for the treatment of bipolar depression.  Biological Psychiatry, (57), 430-432.

Are there any side effects associated with taking Riluzole?

The most frequent side effects associated with Riluzole treatment include headache, nausea, vomiting, dry mouth, constipation, and inner tension.  However, these symptoms do not occur in all patients and may be lessened by lowering the dosage of medication.

Is Riluzole safe?

Riluzole has been FDA approved for Lou Gehrig’s Disease, and, therefore, has passed the agency's rigorous safety evaluation process in those patients.  The FDA has not approved Riluzole for use in patients with depression.

Why do we need a new antidepressant for bipolar disorder?

Despite the availability of a wide range of antidepressant drugs, clinical trials indicate that 30% to 40% of depressed patients 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 medications for bipolar depression.  Studies indicate that the glutamatergic system may play a role in the pathophysiology and treatment of bipolar depression.  Therefore, agents like Riluzole, that likely act by reducing glutamatergic neurotransmission, may represent a novel class of antidepressants.

How much will I be paid to participate in the study?

Research participants will be compensated $100 for completion of the entire screening visit, $50 for completion of the baseline visit and any associated medication tapering visits, and $300 for completion of all 8 treatment visits.  If the subject does not complete the entire screening or baseline visit or drops out of the study prior to completion, then they will be paid based on the percentage of time spent in the study.

Patricia Roy, M.D. is a post-doctoral clinical fellow, working on the Riluzole study. She completed her bachelor's degree in Psychology at the George Mason University and her medical degree at Drexel University College of Medicine in Philadelphia, where she was elected to the Alpha Omega Alpha Honor Society and received a Janet M. Glasgow Achievement Award from the American Medical Women’s Association. Dr. Roy completed her internship year at Lenox Hill Hospital in New York City and she will be completing her residency at Johns Hopkins Hospital.

Chiara Jaffe, MSW, LCSW-C is the study manager on the Rilzuole study.  After receiving her Bachelor’s degree in psychology from Georgetown University, she went on to receive her Master of Social Work from the National Catholic School of Social Service in 1997.  Mrs. Jaffe has experience providing clinical social work services to pediatric, young adult, and geriatric populations through her work as a medical social worker at Georgetown University Hospital and the National Institute of Mental Health.  She also has experience in the design of mental health surveys through employment at Westat, a survey research company.

Annie Chewning is a research assistant for the Riluzole study.  She received her bachelor’s degree in Religion from Davidson College in 2002.  Since graduation, Mrs. Chewning has worked in higher education at both UCSF and the University of British Columbia.

You have entered a web site that describes a Stanley Medical Research Institute funded collaborative study on the treatment of the depressive phase of bipolar disorder. This site is created solely for the purposes of providing background information about the study and tools to enhance participation in the study. If you are seeking immediate help for an affective (mood) disorder, we recommend that you contact a mental health provider. This web site is not set up to provide help or advice to individuals with bipolar disorder, nor to family members of friends of individuals with bipolar disorder.