Mental Health Clinical Trials

Learn about clinical trials for mental health conditions, then search for mental health clinical trials such as clinical trials for depression, anxiety and eating disorders.

Choosing to participate in a clinical trial is an important personal decision. The following frequently asked questions provide detailed information about clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.

What is a clinical trial?

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Clinical trials are generally broken into two categories: interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Who can participate in a clinical trial?

Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

What is informed consent?

Before you take part in a clinical study, it is important to fully understand it and to understand what participation may be like. Researchers will help by providing an "informed consent" statement. This is a document that has detailed information about the study, including its length, the number of visits required, and the medical procedures and medications in which you will take part. The document also provides expected outcomes, potential benefits, possible risks, any available treatment alternatives, expenses, terms of confidentiality, and contact information for people you can call if you have questions or concerns. When needed, a translator may be provided.

Researchers will review the informed consent statement with you and answer your questions. If you decide to participate after reviewing the statement, getting all the information you need, and talking with staff and your family, you will need to sign the informed consent statement. Your signature indicates that you understand the study and agree to participate voluntarily. You may still leave a study at any time and for any reason even after signing the informed consent document.

Sometimes, a potential participant may not be able to give informed consent because of memory problems or mental confusion. Someone else, usually a family member with a durable power of attorney, can give consent for that participant. That caregiver must be confident there is small risk to the participant, and that he or she would have agreed to consent if able to do so.

continue on to find out more about participating in clinical trials or search for mental health clinical trials

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What else should a participant in a clinical trial consider?

You should consider whether you want to empower someone you trust to make health decisions for you if you become sick. This is very important if you choose to participate in a study that changes your regular medication routine, and you and the researchers are unsure about how your body will react. For example, if your thinking becomes impaired, you might make a decision that you would not make if you were thinking clearly. In this case, you may want someone you trust to make a decision for you.

You are not always required to name someone else to make decisions if you become impaired. If you wish to do so, however, speak to the researcher to make sure he or she understands what you want; you may also want to ask what kind of paperwork is required to ensure that your representative will be contacted.

What are the benefits and risks of participating in a clinical trial?

Clinical research can involve risk, but it is important to remember that routine medical care also involves risk. It is important that you weigh the risks and benefits of participating in research before enrolling. When thinking about risk, consider two important questions:

1. What is the chance that the study will cause me harm?
2. If there is a chance of harm, how much harm could I experience?

If you are interested in participating in a study, ask the researchers any questions that will help you decide whether to participate. Taking time to share your concerns will help you feel safe if you do decide to volunteer. (You can find sample questions here) It may be helpful to involve close family members, your doctors, or friends in this decision-making process.

Benefits of a clinical trial

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Research-related care or medicine at no cost.
• The opportunity to learn more about an illness and how to take care of it.
• Help others by contributing to medical research.

Risks of a clinical trial

The nature of the risks depends on the kind of study. Often, clinical studies pose the risk of only minor discomfort that lasts for a short time. For example, in some mental health studies, participants take psychological tests; this is obviously a different kind of risk from undergoing surgery as part of a study. A participant in a study requiring surgery may risk greater complications. Risk can occur in many different ways, and it is important to speak with the research team to understand the risks in a particular study.

Keep in mind that all research sites are required to review their studies for any possible harm, and to share any potential risks with study volunteers.

Risks to clinical trials include:

• There may be unpleasant, serious or even life-threatening side effects to experimental treatment. The treatment you receive may cause side effects that are serious enough to require medical attention.
• The experimental treatment may not be effective for the participant.
• You may enroll in the study hoping to receive a new treatment, but you may be randomly assigned to receive a standard treatment or placebo (inactive pill).
• Whether a new treatment will work cannot be known ahead of time. There is always a chance that a new treatment may not work better than a standard treatment, may not work at all, or may be harmful.
• The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What are side effects and adverse reactions?

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.

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What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
• What kinds of tests and experimental treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the experimental treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the experimental treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?

What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

• Plan ahead and write down possible questions to ask.
• Ask a friend or relative to come along for support and to hear the responses to the questions.
• Bring a tape recorder to record the discussion to replay later.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

Keep in mind that participating in clinical research is not the same as seeing your doctor. Here are some differences:

Participating in Clinical Research: The researcher's goal is to learn about your illness.
Seeing Your Doctor: Your doctor's goal is to treat your condition.

Participating in Clinical Research: The researcher must use standardized procedures. You will probably be removed from the study if your illness worsens.
Seeing Your Doctor: Your doctor will change your treatment as necessary.

Participating in Clinical Research: You will be randomly assigned to a group taking a standard treatment or placebo, also known as an inactive pill (control group), or a group taking a new treatment (treatment group).
Seeing Your Doctor: Your doctor will usually offer standard treatment for your illness.

Participating in Clinical Research: The results from your participation may help researchers develop new treatments and may be published so that other researchers can learn.
Seeing Your Doctor: Your treatment is designed to help you, not to help the doctor learn how to treat people with your illness.

Participating in Clinical Research: In some cases, costs of the study may be covered, and you may receive additional compensation.
Seeing Your Doctor: You will likely need to pay or use insurance for treatment.

Participating in Clinical Research: With your permission, researchers may check in with your doctors to learn about your conditions and past treatments.
Seeing Your Doctor: Your doctor usually won't share your information with researchers. (In some cases, he or she may ask permission to share information).

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Can a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

What rights does a clinical trial participant have?

Deciding whether or not to participate

If you are eligible for a clinical study, you will be given information that will help you decide whether or not to take part. As a patient, you have the right to:

• Be told about important risks and benefits.
• Require confidentiality, or having maintained as private all personal medical information and personal identity.
• Know how the researchers plan to carry out the research, how long your participation will take, and where the study will take place.
• Know what is expected of you.
• Know any costs you or your insurers will be responsible for.
• Know if you will receive any financial compensation or reimbursement for expenses.
• Be informed about any medical or personal information that may be shared with other researchers directly involved in the clinical research.
• Talk openly with doctors and ask any questions.

Once you have decided to participate

After you join a clinical research study, you have the right to:

• Leave the study at any time. Participation is strictly voluntary. You can choose not to participate in any part of the research. However, you should not enroll if you do not plan to complete the study.
• Receive any new information that might affect your decision to be in the study.
• Continue to ask questions and get answers.
• Maintain your privacy. Neither your name nor any other identifying information will appear in any reports based on the study.
• Ask about your treatment assignment once the study is completed, if you participated in a study that randomly assigned you to a treatment group.

What are the possible financial costs to joining a clinical trial?

In some clinical research studies, the medical facility conducting the research pays for your treatment and other expenses. In other trials, you may be responsible for costs. Be sure to ask about possible expenses.

• You or your health insurer may have to pay for some costs of your treatment that are considered part of standard care. This may include hospital stays, laboratory and other tests, and medical procedures.
• If you have health insurance, find out exactly what it will cover. If you don't have health insurance, or if your insurance company will not cover your costs, talk to the researchers or their staff about other options for covering the cost of your care.
• You also may need to pay for travel between your home and the clinic.

Where do the ideas for trials come from?

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

What is a protocol?

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

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What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.

What is a control or control group?

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

What are the different types of clinical trials?

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

What are the phases of clinical trials?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Examples of other kinds of clinical research

Many people believe that all clinical research involves testing of new medications or devices. This is not true, however. Some studies do not involve testing medications and a person's regular medications may not need to be changed. Healthy volunteers are also needed so that researchers can compare their results to results of people with the illness being studied. Some examples of other kinds of research include the following:

• A long-term study that involves psychological tests or brain scans
• A genetic study that involves blood tests but no changes in medication
• A study of family history that involves talking to family members to learn about people's medical needs and history.

What is an "expanded access" protocol?

Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess safety and efficacy of new drugs. Data from the trials can serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these carefully-controlled trials because of other health problems, age, or other factors. For patients who may benefit from the drug use but don't qualify for the trials, FDA regulations enable manufacturers of investigational new drugs to provide for "expanded access" use of the drug. For example, a treatment IND (Investigational New Drug application) or treatment protocol is a relatively unrestricted study. The primary intent of a treatment IND/protocol is to provide for access to the new drug for people with a life-threatening or serious disease for which there is no good alternative treatment. A secondary purpose for a treatment IND/protocol is to generate additional information about the drug, especially its safety. Expanded access protocols can be undertaken only if clinical investigators are actively studying the experimental treatment in well-controlled studies, or all studies have been completed. There must be evidence that the drug may be an effective treatment in patients like those to be treated under the protocol. The drug cannot expose patients to unreasonable risks given the severity of the disease to be treated.

Some investigational drugs are available from pharmaceutical manufacturers through expanded access programs listed in ClinicalTrials.gov. Expanded access protocols are generally managed by the manufacturer, with the investigational treatment administered by researchers or doctors in office-based practice. If you or a loved one are interested in treatment with an investigational drug under an expanded access protocol listed in ClinicalTrials.gov, review the protocol eligibility criteria and location information and inquire at the Contact Information number.

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