PPS has been an active participant in conducting clinical research trials with many sponsors studying many illnesses such as mood disorder, drug addiction, psychotic disorders and Attention Deficit hyperactivity disorders (ADHD). Our goals with our sponsors are:
1- Advance our knowledge about the current commercially available medication regarding expanding the scope of its use in other populations and diagnostic categories.
2- Researching and developing new medications with two important characteristics: A- Medications with least side effect profile to enhance better compliance with medications. B- Medications which are very effective in eliminating clinical symptomatology to help individuals better cope, adjust and manage their illness on the short and long term.
3- Better understanding of the disease process, diagnostic verifications and co- morbidities (relationship between a disease and other illnesses such as presence of substance abuse with mood disorder, which cause what?)
I- what is clinical research?
Clinical research is a study conducted to gain information about the safety and the effectiveness of the medication on individuals participating in the study. The medication could be already available commercially (in the market at the pharmacy) 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 in adult population, we have to research it first to make it available to younger individuals such as children or adolescents. Also, the medication could be experimental in nature meaning it is not available commercially in the market.
II- how an experimental drug becomes approved as a medication and available in the market?
Almost every medication in the market, which starts as “experimental drug” had to go through 3 phases of clinical research studies to be approved to be used by individuals for selected disease.. These phases are:
Phase I: study the experimental drug on a small group of HEALTHY VOLUNTEERS to check on its safety, determine the possible dose and potential side effects.
Phase II: To expand the knowledge obtained from Phase I and apply it on a bigger group of individuals with the disease to continue monitoring for safety mainly and if the drug help to improve the symptoms of the disease researched.
Phase III: to carry on with the information obtained from Phase Phase II and I and applies in on a bigger group of individuals with the disease to check on its effectiveness, safety and to compare the drug to other standard available medication in the market to treat the same individuals with the conditions. For example, after testing Villazadone for Phase I and Phase II for adults with depression, in phase II it has to be compared to other available products such as flouxetine (prozac), citalopram (celexa) and so on.
III- what is “PLACEBO”?
Placebo means that the studied drug shows improvement or worsening of the disease condition due to other reasons than the use of the active ingredients.
An example: a patient start taking a drug and they report back in a couple of days that they were doing “fantastic” and their symptoms are “gone”. After a couple of weeks they come back and the condition is as bad as it was. They were so excited about using the drug as a family member, a friend or even a doctor might have got them initially excited about the drug. However, the drug was not helpful for this patient as the positive effect vanished after a couple of weeks or less.
To control this unwanted positive or negative initial experience, a placebo “SUGAR PILL” is used which looks exactly like the drug with the active ingredient is used to compare if the positive or the negative effect was due to the active ingredient in the drug or just due to other potential bias that was not relevant to the active medication.
IV- what does “BLINDED” mean?
Once again, to ensure the improvement or the worsening of the disease condition was ONLY due to the active ingredients in the drug not due to other biases or irrelevant factors. The participant (SINGLE BLINDED) and the doctor (DOUBLE BLINDED) don’t know what is the participant is taking. It could be the placebo or the drug although they both look exactly the same and no one knows about it during the study time.
V- why do we have to participate in a research study?
Well, we don’t have to, but we should if we could. For example, Depression is the “MOST DISABLING” disease in a human life far beyond cancer or heart attacks. It claims lives, destroy careers, eliminate productivities, vanishes years of human lives with no interest, enjoyments or motivation. Depressed individuals live a life jus from the sideline. They have never got the chance to participate in the fields. It feels like a life passing by and you bitterly watching it from the sideline. Guess, how much medication available in the market to treat depression for the past 50 years. The answer is very concerning. Very few antidepressant medications has been available in the market considering the magnitude of destruction depression cause on individuals, families, communities and societies, it is merely scary to realize that we have only a few resources to treat it. Without fighting the stigma and participations to enhance the research and developments of new and multiple venues of treating depression, it will continue to disable individuals, families, communities and societies.
Additionally, you would receive a free comprehensive evaluation biologically and psychosocially. This particular assessment is offered by other providers with a minimal out of pocket cost about a few thousand dollars expense, as it is not covered by insurance.
Lastly you will be compensated for your time and travel to minimize the burden on your kind participation and willingness to advance our knowledge about the illness, medication management, and better outcome.