A clinical trial is a study to evaluate one or more treatments. Clinical trials are a standard research practice and are done on all medications before they are approved by the Food and Drug Administration. Some trials evaluate the effects of new or existing treatments. Some may study new forms of psychotherapy (talk therapy). Others may study a combination of therapies. Clinical trials are most often conducted by universities but may also be conducted by government agencies or private companies. Many trials are funded by pharmaceutical company grants. All participants are volunteers.
It is important to understand that the objective of a clinical trial is research, not patient care. This does not suggest that trials are designed to harm people—in fact, they are carefully designed with patient safety in mind. However, individuals participating in the trial cannot be guaranteed to receive any new treatments. Some individuals may not receive any treatment at all. The contribution made by participating in a clinical trial is to science first and to the patient second.
Comparing Alternative Treatments
In a typical clinical trial evaluating medications, one group receives a new treatment. A second control group receives a treatment already in use. In some trials, another group will receive a placebo, a sugar pill that has no medicine in it. Most times participants do not know what they are receiving.
Other clinical trials involve a crossover design, where participants are randomly assigned to take a new treatment, a treatment already in use, and/or a placebo for a specified time period. When that portion of the study ends, participants cross over to one of the remaining treatments for another specified time period.
In trials that test new forms of psychotherapy, one group may be randomly assigned to a new form of therapy and another group may receive a standard method of psychotherapy or a combination of psychotherapy and medication.
Benefits of Participation in a Clinical Trial
Any decision to participate in a clinical trial should be made after discussing the pros and cons with your doctor. People participate in clinical trials for a variety of reasons:
- They desire to help advance scientific knowledge about mood disorders and their treatments.
- In the majority of studies, participants are not charged for medications, visits, or tests.
- There may be the chance to receive the attention of multiple medical experts or to receive care at a well-respected medical facility.
- It could be an opportunity to try a new treatment before FDA approval. However, there is no guarantee that you will receive the new treatment in the trial.
Treatment During a Trial
Treatment during a clinical trial almost always follows a protocol, a step-by-step set of instructions about how and when participants receive treatments. This protocol will usually control doses of medication, the number and timing of visits, and any adjustments to treatment.
Requirements for Participation
Admission into a clinical trial is based on a rigid set of requirements.
- You must be diagnosed with the illness that the treatment under study may remedy.
- Sometimes admission requirements will specify a particular subtype of an illness or certain symptoms. You can be severely ill and fail to qualify for a clinical trial if you do not meet these requirements. For example, it might be required that you have depression and are currently taking only one medication.
- Co-existing mental and physical disorders usually must be absent. Co-existing illnesses (also known as co-morbid illnesses) refers to the occurrence of two or more illnesses—such as depression and diabetes—at the same time.
- Excessive alcohol intake or recreational drug use may also disqualify an applicant from participation.
Drawbacks of Participation in a Clinical Trial
Every clinical trial involves a trade-off. Remember that any decision to participate in a clinical trial should be made in consultation with your doctor.
Some Drawbacks of Participation
- There is no guarantee you will receive a new treatment or that the treatment you receive will be better than something you may already be receiving.
- Some trials do not permit the use of treatments other than those administered as part of the study. You may have to stop the treatment you are currently receiving.
- Some trials involve hospitalization or numerous hospital visits for laboratory tests.
- Some trials last a long time—several months to several years.
Questions to Ask Before Joining a Clinical Trial
Before agreeing to participate in a clinical trial, ask questions. Understand the study’s protocol–the plan to be followed. It’s crucial you feel comfortable with the protocol because, to protect the scientific integrity of a trial, straying from protocol is seldom allowed. Be sure you completely understand what is involved in the study before you begin. Do not be afraid to ask questions before you begin or anytime during the trial.
- What treatment is the clinical trial studying?
- Who is paying for the trial?
- How long will the trial last?
- Where will the trial take place? Is hospitalization required?
- Will I have to discontinue my present treatment(s)? If so, could this harm my health?
- If I can stay on my present medication(s), will taking experimental medication be bad for my health?
- If I am involved in a “crossover” clinical trial, can I go back to the first treatment I received if it worked better than the second treatment?
- Can I continue to see my own doctor while in the trial?
- Will everyone involved in the clinical trial get the same treatment? If not, what chance do I have of receiving an existing treatment or placebo? What else will I have a chance of receiving?
- How much time will I have to commit to participate in the clinical trial? How often will the study personnel need to see me? How long will the visits be? What time of day will I need to schedule appointments?
- What are the possible side effects and/or risks? What will be done if I experience side effects during the clinical trial?
- If I don’t receive a new treatment during the clinical trial, will I have an opportunity to try it at the end of the trial?
- If I receive the new treatment and it helps me, will I be able to use it after the clinical trial ends?
- If I have bipolar disorder, what will happen if the treatment makes me rapid cycle or if it makes me manic?
- Are there any fees associated with the study? Will I be paid for my participation?
- What procedures are in place to ensure my confidentially?
- Will I be promptly informed of any findings that might make me want to drop out? For example, if the experimental medication can make me ill.
- Can I drop out at any time, for any reason?
- What kind of follow-up care will I receive after the trial is completed?
- Can I sue if I suffer injury?
Where to Find Out About Clinical Trials
First, ask your physician about clinical trials that relate to your illness. Research organizations conduct clinical trials in most cities.
All clinical trials should be publicly registered, and many are registered at www.clinicaltrials.gov. This site lets you search for clinical trials, get basic information about trials, and learn who to contact for more information.
For another source, call the Office of Public Inquiries at the National Institute of Mental Health (NIMH), (301) 443-4513, or visit NIMH’s web site.
Ads for clinical trials appear in newspapers, magazines, on billboards, on the radio, and on television. These ads usually do not adequately describe the trials, but usually give you contact information. Be sure to review possible risks and benefits with your doctor, family, and friends before participating in any trial.