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Behavioral Health Clinical Trials

Clinical trials are designed to study new tests or treatments so that more can be learned about how they impact humans. For example, when developing a vaccine, clinical trials will be conducted to learn as much as possible about the vaccine, how it works, long-term effects, and so on. When enough information is gathered to deduce that the vaccine is safe for human use, then it will be approved for such.

These types of trials are extremely important when it comes to mental health care, as countless medications have been developed to help treat symptoms associated with a variety of different mental health conditions.

Improving Mental Health Care Results Via Clinical Trials

Neuroscience Research Institute conducts various mental health clinical trials that help in provide high-quality care for participants. Clinical trials can test the safety and efficiency of new treatments in a controlled manner with volunteer members. For any newly developed drug or treatment method for curing obesity or depressive disorders, clinical trials are necessary to enhance the medication and improve the patient care. It also provides new advanced treatments to volunteers before they are publicly available.

Neuroscience Research Institute conducts Phase I-IV Clinical Trials for Pharmaceutical Companies, Contract Research Organizations (CRO’s), Biotechnology Companies, and Other Research Organizations in South Florida, Palm Beach Count, West Palm Beach. We’re a leader in clinical trials research. We provide high-quality psychiatric clinical trials along with ethical care, and innovative treatment which meet medical, scientific, and professional needs of clients and sponsors.

Neuroscience Research Institute has a dedicated team of highly qualified researchers in clinical trials. With over 17 years of clinical trials experience in both academic and non-academic settings. Our diverse team consists of Psychiatrists, Multi-Specialty Physicians, Psychologists, Pharmacists, Nurses, Social Workers, Clinical Research Coordinators, and other support staff. Our staff has extensive experience in conducting safety and efficacy studies in both outpatient and inpatient facilities. Moreover, we’ll provide quality education to all of our interested and current patients looking to learn more about our clinical research trials.

Behavioral Health Clinical Studies

Most recently these mental health clinical trials have been conducted:

  • Adult ADHD clinical trial
  • Adult Depression study
  • Adult Bipolar Study clinical trial
  • Early Onset Alzheimer’s clinical trial
  • Depression with suicidal ideation clinical trial
  • Dementia with Hallucinations and Delusions clinical trial

Depression Treatment Clinical Trials

We conduct studies for both adults and adolescents. While it is one of the most prevalent psychological disorders in the United States, depression can be hard to recognize. Depression is associated with negative feelings, inability to sleep well, low energy, appetite loss, and no longer enjoying one’s hobbies, passions, and social relationships. Feelings of hopelessness, sadness, ennui, and anxiety can be completely normal, but if they continue for over two weeks in a stretch, that may also be a sign of depression.

Bipolar Treatment Clinical Trials

Bipolar disorder is characterized by long lasting episodes of “mania”, and “depressive” states. People suffering from bipolar disorder experience such extremes of emotion and energy that it can affect their ability to think clearly. Episodes may last as long as a few months or pass within less than a day. Manic episodes involve emotional volatility and behaviors like impulsiveness, talkativeness, less need for sleep, excessive risk taking, euphoria, and irritability. Depressive episodes involve extreme depression, suicidal thoughts, an increased need for sleep, and feelings of hopelessness or worthlessness. Bipolar disorder affects around 5.7 million Americans.

ADHD – Attention Deficit Hyperactivity Disorder Clinical Trials

In this condition, a short attention span, an inability to focus, poor organizational skills, an inability to follow through on goals and assignments, and poor academic or work performance. Although ADHD is usually thought of as a childhood disorder, adult ADHD is an increasingly documented problem.

Anxiety Treatment Clinical Trials

Occasional feelings of nervousness or anxiety are nothing to worry about, but anxiety disorders are potentially debilitating conditions. Feelings of anxiety over everyday occurrences like basic socialization, cooking, or going outside are signs of an anxiety disorder. Feeling anxious or afraid, which may be as extreme as a sense of impending doom, may even occur for no apparent reason. Muscle tension, trouble sleeping, nausea, vertigo, clammy hands and feet, and numb or tingling sensations in the extremities are possible physiological symptoms of anxiety and anxiety disorders.

Alzheimer’s Treatment Clinical Trials

This neurodegenerative disorder inhibits memory in a variety of ways and causes brain functions to deteriorate. The deterioration is progressive and causes the patient to have difficulty in memory retention and recollection. Eventually, it can affect the body’s functions and will lead to premature death.

Schizophrenia Treatment Clinical Trials

Schizophrenia is a condition that involves symptoms such as hallucinations, especially auditory, though visual hallucinations also occur. Dependent on the severity of their condition, people suffering from schizophrenia can sometimes find it difficult to separate their hallucinations from what is happening in reality. In addition to hallucinations, sufferers may experience delusions, disorganized speech patterns, erratic behavior, feelings of hostility, and lack of facial expression.

Clinical Trial Studies Available now

Currently, Neuroscience Research Institute is looking for participants to join a clinical trial study. If you would like to learn more about this study click here or call (561) 459-9966. We also offer free memory evaluations.

Inpatient And Outpatient Clinical Trial Studies Available. Our Facilities Are Located in Palm Beach County Florida.

Clinical Trial Sponsors

Major Pharmaceutical Sponsors

  • ABBOTT LABORATORIES 
  •  ASTRA ZENECA 
  •  AVENTIS / HOECHST MARION ROUSSEL 
  •  BRISTOL MEYERS SQUIBB 
  •  ELI LILLY AND COMPANY 
  •  GLAXO SMITH KLINE 
  •  JANSSEN PHARMACEUTICAL 
  •  MERCK 
  •  NOVARTIS / SANDOZ PHARMACEUTICALS 
  •  ORGANON 
  •  PFIZER, INC. 
  •  SOLVAY 
  •  DAINIPPON SUMITOMO PHARMA AMERICA, INC. (DSPA) 
  •  TAKEDA PHARMACEUTICALS

CRO’s (Contract Research Organizations)

  •  COVANCE 
  •  ICON 
  •  I3 / INGENIX PHARMACEUTICAL SERVICES / WORLDWIDE CLINICAL TRIALS 
  •  LINEBERRY RESEARCH ASSOCIATES 
  •  OMNICARE CLINICAL RESEARCH 
  •  PAREXEL 
  •  PPD PHARMACO 
  •  QUINTILES

Clinical Trials Research

Indications

  • Substance Use Disorders
    • Alcohol Use Disorders
    • Opiate Use Disorders
    • Cocaine Use Disorders
    • Methamphetamine Use Disorders
  • Anxiety Disorder
  • Attention Deficit Disorder
  • Bipolar Depression
  • Bipolar Mania / Hypomania
  • Depression in Aging
  • Depression, Treatment Resistant
  • Depressive Disorders
  • Dysthymia
  • Generalized Anxiety Disorder
  • Impotence
  • Insomnia / Sleep Disorder
  • Major Depression
  • Mood Disorders with Pain Syndromes
  • Obesity
  • Obsessive / Compulsive Disorder
  • Panic Disorder
  • Pharmacokinetics, Mental Disorders
  • Pharmacokinetics, Schizophrenia and Related Psychotic Disorders
  • Post-Traumatic Stress Disorder
  • Psychoactive Substance Use Disorder· Psychosis
  • Psychosis in Dementia
  • Schizophrenia / Schizoaffective Disorder
  • Schizophrenia, Treatment Resistant
  • Seasonal Affective Disorder· Sexual Disorders
  • Social Phobia

Why Volunteer for a Mental Health Clinical Trial?

The development of a new drug is a long and complicated journey. The role of the doctors, nurses, and other support staff is a critical one. Most of the drugs in use today have, after their initial discovery, undergone a range of laboratory tests using cell cultures, isolated tissues, and animals. If a drug shows clinical potential, it may be used in humans only after successful completion of pre-clinical toxicity tests on different animal species. For the 50,000 or so substances which are synthesized in the laboratory, approximately five will reach the stage of full tests in humans-only one of these will actually be safe and effective enough to be marketed.

After much of the laboratory testing is completed, the first use of the drug in humans can take place. The tests on humans can generally be classified into four phases:

Phase I are normally done in healthy volunteers, usually in special hospital units equipped for performing these trials. Studies on the drug’s absorption, distribution, metabolism, and excretion (pharmacokinetics) are done.

Phase II are generally the first trials in patients, conducted to mainly give an idea of efficacy, to identify the optimal dose, and to provide the first indication on safety in patients. Up to a few hundred patients are involved in this phase.

Phase III are the main assessment of safety and efficacy of a drug. Many more patients are treated in phase III trials-up to several thousands.

Phase IV are those performed after obtaining a license to market the drug. Contrary to Phases II and III, problems associated with long term use of the drug or rare adverse events can be detected.

GCP (Good Clinical Practice)

The basic principles of GCP (Good Clinical Practice) are first for the protection of the research patient or volunteer and second to collect data that can be replicated and is correct. One of the reasons that GCP was introduced and accepted was because of concern about drug safety. In particular there was public anxiety among regulators about the quality and reliability of the research data submitted to regulatory authorities. Fraudulent data could jeopardize patient safety or could cause rejection of an application for a new drug with potential for curing illness. Fraudulent data usually emphasized the efficacy and underplayed the toxicity of a drug.

WHY do research?

Pharmaceutical companies around the world are engaged in more research now than ever in the history of medicine. It is through the research process that new treatments are discovered to treat illnesses. Without research, many diseases that have been controlled, or have been cured would still plague the world.

WHAT are the goals?

Various government agencies are charged with regulating medications, medical devices, and medical treatments. The primary goals of this regulation are to make sure that the medications available in the United States are both safe and effective in the treatment of particular illnesses. At times, research also looks into new uses for medications that are currently available by prescription, or investigate the possibility of medications being made available without prescription. Other areas of research include Pharmacoeconomics which is the science of looking at the cost of medications, and the worth of that expense to society.

WHO does research?

Research is conducted in a number of different settings. Universities, government agencies, and research centers are a few of these research settings. The National Institutes of Health, the Food and Drug Administration (FDA), private foundations, and pharmaceutical companies, as well as other branches of industry and government may request or sponsor research.

HOW are participants chosen?

All participants in clinical trials are volunteers. For some types of studies, participants for a study who are healthy, and not suffering from any current illness are recruited. These studies are largely for the purpose of investigating the metabolism of a drug. There is often no therapeutic benefit to those participants other than contributing to medical science, and on some occasions a payment for their time and assistance. For most studies, participants must be diagnosed with a specific illness or disease. A physician or other licensed professionals will take a detailed history, perform a physical examination, and review laboratory tests to make sure that the diagnosis is correct, and that no other illness will confound the results of the study, or endanger the patient’s health or safety. Volunteers come to the clinic from a variety of sources including physician and hospital referral, referral by previous study participants, and response to an advertisement or other public notices.

IS research safe?

Before a medication or treatment can be used in a general medical practice, it has to be proven to be safe in a laboratory or research clinic setting. Before a volunteer begins participation in a research study, the potential risks and side effects of the experimental medication are explained to them in detail. The participant signs a consent form that reviews the study design, and the safety and efficacy profile of the medication being studied. The research itself is conducted under the supervision of a physician and their staff, and a medical monitor from the sponsoring agency, organization or from the pharmaceutical company.

CAN I have a copy of my records?

All participants in a clinical research study have a medical chart at the Research Company. This includes the results of the initial history and physical examination, laboratory tests, cardiograms, and the results of any other medical procedures. Upon request, these records can be sent to your own physician for inclusion in your permanent record.

WHO reviews the ethics of the research?

For each study, a copy of the experimental protocol, and complete information about the medication is reviewed by an independent investigational review board (IRB) or ethics committee. No volunteers can be entered into a research study before this committee has approved of the research protocol, the advertisements for the research, and the consent form that explains the research to the participant.

WILL I be paid to participate?

Payment for participation in clinical trials varies according to the research project, medication, disease under investigation, and “phase” in the development cycle of the study. Often the cost of transportation will be reimbursed. For phase I and early phase II studies, where there is no long-term therapeutic benefits to participants, often compensation is given for the time involved, and any discomfort caused by the experimental procedures.WHY do some studies include a placebo?

For a medication to be shown effective, it has to be compared with an inactive substance or placebo medication. If it is no better than the placebo, the conclusion from the research is that it doesn’t work. In addition, experimental medications are often compared against a marketed compound. To be a useful medication, it should be as effective as medication currently on the market, and better than placebo. Interestingly, 30-40% of volunteers who take placebo medication get relief of their symptoms.

WHEN the research is over, what happens to me?

Because volunteers have been diagnosed with an illness or disease, at the end of their participation, follow-up medical care is often provided. This service includes follow up visits with the physician, or someone on their staff, and in some cases, medication for three months. We then refer patients back to their regular physicians, with recommendations for treatment.

Informed consent is the process designed to give volunteers the information that they need to decide about participating in a clinical study. This process allows the volunteer to ask questions and to exchange information freely with the clinical investigator. The clinical investigator is responsible for ensuring that informed consent is obtained from each research volunteer before that person participates in the research study.

WHO is the Institutional Review Board (IRB)?

The IRB is a group of healthcare professionals and non-scientific members which must review and approve a clinical study before it begins. The IRB carefully reviews study activities because its primary responsibility is to protect the safety and rights of study participants.

Online Resources

  • World Health Organization: www.who.int/en/
  • National Institutes of Health(NIH): www.nih.gov
  • Center for Disease Control: www.cdc.gov
  • Clinical Trials Information: www.clinicaltrials.gov
  • Food and Drug Administration: www.fda.gov
  • The Office for Human Research Protections: ohrp.osophs.dhhs.gov
  • National Bioethics Advisory Commission: www.bioethics.gov
  • Agency for Health Care Policy and Research: www.ahcpr.gov
  • HIPAA Privacy Policy: www.hrsa.gov/website
  • Current Good Manufacturing Practices: www.aphis.usda.gov
  • International Conference of Harmonization: www.ich.org
  • Clinical Trials: www.clinicaltrials.com
  • Public Responsibility in Medicine and Research: www.primr.org
  • Free Drugs for Patients: www.helpingpatients
  • Patient Medication Guide: www.ahrq.gov/consume
  • National Alliance for the Mentally Ill: www.nami.org
  • Depression and Bipolar Support Alliance: www.dbsalliance.org