Behavioral Health Clinical Trials
The Middlesex Hospital Behavioral Health Department has participated in 30 clinical trials with 10 different sponsors and universities since 1999. With four investigators, a full-time certified clinical research coordinator, and a psychologist, we are interested and able to conduct research in all areas of CNS.
Our investigators are certified by the American Board of Psychiatry and Neurology, with additional certifications in Child and Adolescent Psychiatry, Addiction Psychiatry, and Geriatric Psychiatry. We have experience working with inpatient and outpatient clinical trials ranging from Phase II to IV. We also have experience working with older adults, and child/adolescent clinical trials.
What is a clinical trial?
A clinical trial (also known as clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
What are the different types of clinical research?
- 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, vitamins, vaccines, 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: 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 whether 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 describe additional information including the drug’s risks, benefits, and optimal use.
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 science.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. The factors that allow someone to take part in a clinical trial are called "inclusion criteria" and those that disallow someone from taking part in a trial are called "exclusion criteria." These criteria are based on such factors as age, gender, and 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. 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.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors, nurses, study coordinators, 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 doctors visits than the participant would normally have for an illness or condition. Clinical trial participation is most successful when the study directions are carefully followed and there is frequent contact with the research staff.
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 study plan which details what research will be conducted during the study.
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 the 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 and welfare 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.
What are the benefits and risks of participating in a clinical trial?
Clinical trials that are well-designed and well-executed enable eligible participants to:
- Play an active role in his or her 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.
- Help others by contributing to medical science
But, there are risks to clinical trials:
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective for the participant.
- The study may require more of their time and attention than a non-protocol treatment would, including visits to the study site, more treatments, hospital stays or complex dosage requirements.
Can a participant leave a clinical trial after it has begun?
A participant can leave a clinical trial, at any time for any reason. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving.
Behavioral Health Programs/Groups/Classes (from Community Medicine)
- Anxiety Disorder Group
- Managed Service System (MSS)
- Bereavement Support Group
- Medication Management Group
- Bipolar Disorder Group
- Older Adults with Depression and Anxiety Group
- Care Coordination (Local Systems of Care)
- Prevention and Education
- Caregiver Support Group
- Psychiatric Day Treatment Program
- Dual Diagnosis Group
- Service Review Team and Case Management Services
- Focus on Survivorship and Prevention
- Short Term Case Management for Young Parents and Pregnant Women
- Free Smoking Intervention Service
- Stress and Coping
- IMPACT - Immediate Mobile Psychiatric Adolescent and Child Team
- Substance Abuse Programs
- Life Skills Group
- Women in Transition