The development of new medications plays a central role in the advancement of medical treatments and the improvement of patient quality of life. All new medications go through several stages or phases of testing to demonstrate their safety and effectiveness before physicians can prescribe them to their patients. At the heart of this process are research studies called clinical trials. In a clinical trial, the new medication is typically compared to either a currently approved medication and/or a placebo (a pill that looks like the new medication but contains no active ingredients).

Behavioral Health Clinical Trials

Although remarkable progress has been made over the past 20 years in defining and treating the various forms of mental illness, most treatments are either not effective for everyone or may produce significant side-effects in some individuals. As a result, there is an ongoing need for the development of new medications within the mental health field.

Participating In A Clinical Trial

There is no single reason that individuals choose to participate in clinical trials but many do so in the hope that the new medication will provide them with relief from their symptoms, and produce few and/or mild side effects. Some choose to participate because they recognize that even if they do not experience a direct personal benefit from participating in the trial, the research study results will potentially increase the level of understanding of the disorder, and contribute to the development of more effective forms of treatment.

Your Informed Consent

Participation in a clinical trial is completely voluntary. The decision to participate should only be made after thorough consideration of all available information. Before you enter a clinical trial, the study doctor and study staff will fully describe the purpose of the study, what is expected of each participant, and the potential risks and benefits that you may experience.

All potential participants are presented with a document that contains this information as well as a complete description of each element of the trial. You must read, discuss and finally sign this document, called the “Consent Form,” before any study related procedures can be performed.

Throughout the course of the trial, any new information that becomes available regarding trial procedures or medication will be provided to you in a timely manner. You can choose to end your involvement in a clinical trial at any time and for any reason.

Safety and Well-being

The safety and well-being of a participant in a clinical trial are the primary concerns of the clinical trial staff. In order to insure these concerns are addressed, your participation in the clinical trial includes meeting with the trial doctor and staff on a frequent basis to monitor progress. It is very important that you attend all visits, honestly answer all questions regarding the trial medication and your health, and follow the instructions of the clinical trial staff.

Benefits to Clinical Trial Participation

Some of the benefits of participating in a clinical trial include:

  • Taking an active role in your own treatment.

  • The opportunity to receive treatments not otherwise available.

  • Receiving skilled medical care at no financial cost.

  • The opportunity to contribute to the current state of medical knowledge.

Current Clinical Trials

Charak Clinical Research Center is currently conducting clinical trials involving the following mental health diagnoses.

  • Adolescent Schizophrenia Disorder - OTSUKA
    A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13 -17 years old) With Schizophrenia
    Main Criteria for Inclusion: Male or Female 13-17 years of age, meets DSM-V criteria for Schizophrenia, has shown response to previous antipsychotic treatment
     This study is ~10 weeks long. Currently enrolling.

       For more information  visit:https://clinicaltrials.gov/ct2/show/study/NCT03198078?      cond=Adolescent+Schizophrenia&cntry=US&state=US%3AOH&draw=3&rank=10#contacts

  • Adult Bipolar Depression - Intra-Cellular Therapies 
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients with Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder (Bipolar Depression).
    Main Criteria for Inclusion: Male or Female 18- 75 years of age, meets DSM-V criteria for Bipolar I or Bipolar II Disorder, currently in a major depressive episode, has a lifetime history of a least one manic, mixed or hypomanic episode
     The study is ~10-12 weeks long. Currently enrolling.

        For more information visit: https://clinicaltrials.gov/ct2/show/NCT02600494?recrs=a&cond=Bipolar+I+and+Bipolar+II+Disorder%2C&cntry=US&rank=3

  • Adolescent Major Depressive Disorder - Allergan
    A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients with Major Depressive Disorder
    Main Criteria for Inclusion: Male or Female 12-17 years of age, DSM-IV-TR criteria for MDD, reliable caregiver
    Subjects will discontinue current medication and start investigational product. The study is ~10 weeks long. Currently enrolling.

​       For more information visit: https://clinicaltrials.gov/ct2/show/NCT02431806?term=lvm-md-11&rank=1

 

Clinical Trials

 
 

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