Clinical research is a study conducted to gain information about the safety and effectiveness of medications being taken by individuals participating in the study. The medication could already be available commercially (in the market) for a specific disease and/or selected individuals (age, gender, ethnic background) and the study needs to research if it could be used for other groups of individuals. For example, if a medication was approved for the adult population, we have to research it first before making it available to younger individuals, such as children or adolescents. On the other hand, the medication could be experimental in nature, meaning it is not available commercially in the market.
Almost every medication in the market once started as an “experimental drug”, and had to go through three phases of clinical research studies to be approved. These three phases are:
Phase I: Study the experimental drug on a small group of healthy volunteers to determine its safety, the possible dose, and the potential side effects.
Phase II: Expand the knowledge obtained from Phase I and apply it to a bigger group of individuals with the disease to continue monitoring for safety, and to determine if the drug helped to improve symptoms of the disease being researched.
Phase III: Apply the information obtained from Phases I and II to a bigger group of individuals with the disease to determine its effectiveness and safety, and to compare the drug to other standard available medications in the market that treat the same conditions. For example, after completing Phases I and II for a medication called Villazadone that treats adults with depression, in Phase III it will be compared to other available products such as Fluoxetine (Prozac), Citalopram (Celexa), and so on.
Placebo means that the studied drug shows improvement or worsening of the disease condition due to reasons other than the use of the active ingredients.
Example: A patient starts taking a drug and they reports back in a couple of days that they are doing “fantastic” and their symptoms are “gone”. After a couple of weeks, they come back and the condition is as bad as it was before starting the drug. The drug was not helpful for this patient, as the positive effect vanished after a couple of weeks or less, due to the initial over-excitement.
To control this unwanted positive or negative initial experience, a placebo “SUGAR PILL” is used. The placebo looks exactly like the drug with the active ingredient, and is used to compare whether or not the positive or negative effect is caused by the active ingredient in the drug, or just due to other potential bias that was not relevant to the active medication.
To ensure whether or not the improvement or worsening of the disease condition was only due to the active ingredients in the drug, the participant (SINGLE BLINDED) and the doctor (DOUBLE BLINDED) don’t know what the participant is taking. It could be the placebo or the drug, because they both look exactly the same and no one knows about it during the study time.
Depression is the “MOST DISABLING” disease in a human life, far beyond cancer or heart attacks. It claims lives, destroys careers, eliminates productivities, and vanishes years of human lives with no interest, enjoyments or motivation. Depressed individuals live a life from the sidelines. They have never gotten he chance to participate on the field. It feels like life is passing by and you are bitterly watching it from the sideline. Very few antidepressant medications have been available in the market considering the magnitude of destruction depression causes for individuals, families, communities, and societies. It is scary to realize that we have only a few resources to treat it. Without fighting the stigma and finding participants to enhance the research and developments of new medications to treat depression, it will continue to disable individuals, families, communities, and societies.
Additionally, participants receive a FREE comprehensive evaluation, biologically and psychosocially. This particular assessment is offered by other providers for a few thousand dollars out-of-pocket, as it is not covered by insurance.
Lastly, participants will be compensated for your time and travel to minimize the burden for your kind participation. Your willingness to advance our knowledge about the illness and medication management will result in a better outcome for many.
Some of these medications are readily available in the market and we are investigating if they could be used for other disorders. If so, then you would continue taking it by getting a prescription as you do for every other medication. If the research medication is not commercially available, the pharmaceutical industry has an obligation to continue providing the medication to you until it is commercially available.
You can always withdraw from participation since it is voluntary to begin with. However, it is always advisable to brainstorm with family members and discuss in detail with your research staff about any questions or foreseen difficulties in ending participation in these programs. When participants drop out of these studies without a valid or medical reason, everyone, including the participant, loses time, efforts, and money invested in these previous steps that will not be utilized.