Research
Kolade Research Institute is proud to be involved in the mental medical breakthrough with patients who have been diagnosed with Major Depression disorder, Bipolar, Schizophrenia and other mental disorders.
Our team is very selective when it comes to a safe clinical study that would possibly offer exciting and promising treatments for our patients. The studies we chose will hopefully help benefit patients in the treatment of their psychiatric disorders. Study subjects are carefully selected base on the inclusion and exclusion criteria.
Principal Investigator
Akindele Kolade, MD
Dr. Kolade has more than 15 years of Clinical Research experience involving Adolescent and Adults patients with diagnosis such as : Schizophrenia, Alzheimer’s Disease , Bipolar Disease, Major Depression Disorder, ADHD and other Psychiatric Disorders. He continues to participate in ongoing studies to find new treatment for subjects with psychiatric disorders.
What is a Clinical Research Coordinator?
The Clinical Research Coordinator is responsible for the organization the study trials and ensure the trials are up to GCP standards. The Clinical Research Coordinator is the main point of contact for both trial sponsors and participants. They are also responsible for answering any questions regarding the logistics of the study and coordination of care. They are informed with each study protocol to advocate the safety of the subjects and the integrity of the study.
Kolade Research Institute Staff
Monique Myles
Certified Clinical Research Coordinator
Monique has 5 years of experience in clinical research. She has worked in the research fields of Nephrology, Dermatology, Obesity, Children Pediatrics and Women’s Health. Monique is GCP certified and is currently focused on clinical trials related to Schizophrenia in adolescents and adults.
Chaysie Iloreta
Research Assistant | Medical Assistant
Chaysie has 2 years of experience in Medical Assisting; performs basic clinical procedures and is GCP certified. Chaysie works to assist the Clinical Research Coordinator with any study-related tasks.
Clinical Research Rater
What is a Clinical Research Rater?
Clinical Research rater is used within clinical trials to improve the consistency of subjective data collected from patients, caregivers/observers, and clinicians/interviewers. Data stability is critical for data analyses. To that end, standardized instruments are translated and localized to ensure that questions are psychometrically equivalent.
Kolade Research Institute has three qualified experienced raters on-site for the currently active studies.
Dr. Nicole Dionisio, PhD
Clinical Research Rater
Heidi Stark-Bank, Psychologist
Clinical Research Rater
Active Clinical Trials:
Active Trial I & II: A multicenter, Randomized, Double-blind, placebo- and Active-controlled Trials to Evaluate the Efficiacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 years old) With Schizophrenia.
Active Trial III: A Phase III, Randomized, Double-Blind, 12-week study of ALKS 3831 vs Olanzapine to Evaluate Weight Gain as assessed by change in BMI Z-score in Pediatric Subjects with Schizophrenia or Bipolar I Disorder.
Active Trial IV: To Evaluate the Safety, Tolerability, and Effect of Risperidone Extended-Release Injectable Suspension for Subcutaneous use as Maintenance Treatment in both adults and adolescent patients (13-65 years old) with Schizophrenia.
Pending Clinical Trial:
A Double- blind, Placebo-and Active Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patient with Major Depressive Disorder.
Disorders:
Schizophrenia
What is Schizophrenia?
Schizophrenia is a serious disorder which affects how a person thinks, feels and acts. Someone with schizophrenia may have difficulty distinguishing between what is real and what is imaginary; may be unresponsive or withdrawn; and may have difficulty expressing normal emotions in social situations.
What causes Schizophrenia?
The cause of schizophrenia is still unclear. Some theories about the cause of this disease include: genetics (heredity), biology (abnormalities in the brain’s chemistry or structure); and/or possible viral infections and immune disorders.
Bipolar I Disorder:
Bipolar 1 is the type most easily diagnosed as it contains the most pronounced elevated mood, called mania. A person with bipolar 1 (also noted as bipolar i) has episodes of both mania and depression. The presence of these episodes are the hallmark symptoms of bipolar I.
What are the causes of Bipolar?
The exact cause of bipolar disorder is unknown.
Major Depression Disorder
Depression is a mood disorder that causes a persistent feeling of sadness and loss of interest. Also called major depressive disorder or clinical depression, it affects how you feel, think and behave and can lead to a variety of emotional and physical problems. You may have trouble doing normal day-to-day activities, and sometimes you may feel as if life isn’t worth living.
What causes Major Depression Disorder?
It’s not known exactly what causes depression. As with many mental disorders, a variety of factors may be involved, such as:
Biological differences. People with depression appear to have physical changes in their brains. The significance of these changes is still uncertain, but may eventually help pinpoint causes.
Brain chemistry. Neurotransmitters are naturally occurring brain chemicals that likely play a role in depression. Recent research indicates that changes in the function and effect of these neurotransmitters and how they interact with neurocircuits involved in maintaining mood stability may play a significant role in depression and its treatment.
Hormones. Changes in the body’s balance of hormones may be involved in causing or triggering depression. Hormone changes can result with pregnancy and during the weeks or months after delivery (postpartum) and from thyroid problems, menopause or a number of other conditions.
Inherited traits. Depression is more common in people whose blood relatives also have this condition. Researchers are trying to find genes that may be involved in causing depression.
What are clinical trials?
Clinical trials are voluntary research studies of humans that are designed to answer questions for the necessity of the approval by the FDA for new treatments.
Individuals who participate are voluntary in the clinical trials for various reasons. Their participations allow access to new treatments that are not yet approved by FDA or available to the public. Clinical trials are monitored carefully with additional testing at no cost. Voluntary participation for other individuals takes pleasure in helping others and contributing to medical breakthrough in the future.
What is a Clinical Research Coordinator?
Our Clinical Research Coordinator have years of experience in coordinating clinical studies and would be the point of contact for participants once the physicians have deem the patient qualified for the study. They are also the point of contact of Sponsors who would select our site to participate in their trials. The Clinical Research Coordinator helps to answer questions regarding the logistics of the study and coordinate the care. They are informed with each study protocol to advocate the safety of the subjects and the integrity of the study.
What are the Phases in a Clinical Trial?
Phase 1 Trials: A small number of participants are used to test an investigational drug or treatment. The main focus is to determine the safety of the drugs in humans. They evaluate the safe dosage range and identify possible side effects from the drug/treatment.
Phase 2 Trials: After completing the Phase I trials, the information is used to treat a slightly large limited number of participants. Phase II used the information gathered form Phase I to further evaluate the safety and effectiveness of the drug/treatment.
Phase 3 Trials: The experimental treatment is given to a large group of participants in a variety of clinical settings to evaluate the safety , effectiveness and to monitor the side effects.
Phase 4 trials: Once the drugs has been approved by the FDA this is when post marketing studies are conducted to continue to gain more information about the benefits and safety of the drugs.
What is involved?
As a study subject you will need to committed to participate in the study but it is voluntary and you can withdraw from the study at any time. The visits will be with the physician, the study coordinator and the counselor. There will be some blood work involved, EKG and some assessments.
What is the duration of the study?
The duration of the study varies. The length of the study can last 6 months to 2 years and office visits can be approximately 2-4 hours depending on the Sponsors and what is needed to get FDA to approve the investigational product.
For more details and see if you may qualify for the study, please contact Monique at:
Email: mmyles@koladeresearchinstitute.com
Contact #: (725) 251-2629