About Participation in Studies
Below are answers to questions that prospective research participants frequently ask.
The DES offers free treatment with antidepressant medications, most of which have been approved by the FDA for depressed men and women between the ages of 18 and 65. Consistent with the clinic’s goal to identify methods to match specific treatments to different forms of depressive disorders, some protocols include procedures (e.g., the dichotic listening test) that serve for diagnostic purposes only and that do not affect a patient’s response to treatment. Treatment studies vary in length from eight weeks to approximately 6 months. Following the end of a study, all patients are eligible for 3 months of free treatment. Patients may terminate study participation at any time and for any reason.
Are All Medications Used in Des Treatment Studies Approved by the Food And Drug Administration (FDA)?
Most studies at the Depression Evaluation Service (DES) involve FDA-approved medications, some of which may have been recently marketed and are being studied in a clinical trial. Treatment with medications that have not yet reached the U.S. market involves study of these medications’ efficacy (i.e., since their safety has already been established, research examines how effective they are in treating depression). The FDA status of a particular drug and the possible risks and benefits of a treatment are fully discussed with patients before study participation begins.
Some patients may experience side effects to antidepressant medications that are generally mild and short-lived (e.g., headaches, dry mouth, nausea, skin rash). Side effects are closely monitored during treatment. Patients who are unable to tolerate a given treatment will be offered alternative treatment.
Fully trained psychiatrists, all of whom hold teaching appointments at Columbia University’s College of Physicians and Surgeons, conduct the treatment. A social worker and a team of support staff work closely with them to educate and monitor patients. While frequency of appointments varies depending on the study, patients generally meet with one of the psychiatrists initially every week and then every two weeks. Additional visits are available if needed. Patients and/or the treating doctor may elect at any time in the study to delay dose increases of medication, to decrease the dose of medication, or to stop the medication. Although initial evaluation appointments are during daytime hours, evening appointments are available for treatment visits.
All treatment, including psychiatric visits, routine blood tests, and medication, is free. Medication that is not required by the study is not provided.
Men and women between the ages of 18 and 65 who suffer from depression and who are medically stable are eligible for a no-cost screening. Each study has particular eligibility criteria. To inquire further about study eligibility and to schedule a no-cost screening, please call the DES at 646.774.8000 or e-mail at email@example.com.
After contacting the DES by phone (646.774.8000) or by e-mail (firstname.lastname@example.org) and after undergoing a brief telephone screening, interested patients have a detailed interview with a staff clinician, followed by an appointment with a research psychiatrist for a comprehensive diagnostic evaluation, which allows the psychiatrist to determine the patient’s eligibility for studies and allows the patient to learn more about the studies. Before entering a study, patients review the study procedures with a staff member, read and sign a consent form, and receive a medical assessment, including a physical examination, an electrocardiogram and blood tests, which are at no cost to the patient. All inquiries and treatment records are strictly confidential.