Charak Clinical Research Center
Quest for Cures
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Our Mission
To increase our knowledge of the latest available treatments in behavioral health care, and to achieve the fullest understanding of our patients. This two-fold approach assures our patients of the best possible care.
Quest for Cures
Charak Clinical Research Center takes its name from the noted Indian physician from the 1st century, Charak, the author of one of the oldest books on medicine, The Charak Samhita. Charak was one of the first medical practitioners to champion the principles that knowledge of all available remedies, and a thorough understanding of the patient, are the critical elements to providing the most appropriate care for each unique individual.
Why You Should Take Part
You can be on the forefront of innovation in the mental health space. Medications and treatments that were not previously available to you can be used to help you when you need it most.
Current Trials
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.
LivaNova Treatment Resistant Bipolar Depression
Diagnosis: Bipolar I or II
Purpose: A long term study of the safety & efficacy of VNS (Vagus Nerve Stimulation) as an adjunctive therapy to individuals diagnosed with Treatment Resistant Bipolar Depression compared to a no-stimulation control group.
General Inclusion Criteria: Females or males 18 years of age or older.
During their current depressive episode, they have had an inadequate benefit from at least four antidepressant treatments including medications, psychotherapy, ECT, rTMS or pharmacological interventions.
In generally good physical health.
No substance abuse or dependance during the 12 months prior to screening.
Additional Information: Subjects who complete this study may be eligible to participate in a long term open-label follow-up study of VNS without comparators, i.e., all participants will receive VNS for up to 48 months.
Otsuka Pharmaceutical Treatment Resistant Depression Study
Diagnosis: Major Depressive Disorder
Purpose: A six-week study of the efficacy, safety and tolerability of Centanafadine alone or as an adjunct therapy to an SSRI.
General Inclusion Criteria:
Females or males ages 18 to 65 with Major Depressive Disorder, without psychotic features, who have had an inadequate response to at least 1 and no more than 3 antidepressant therapies.
Janssen Treatment Resistant Study
Diagnosis: Major Depressive Disorder
Purpose: A 43-day study of the safety, efficacy and tolerability of Aticaprant in addition to standard medication of SSRI/SNRI.
General Inclusion Criteria:
Female or males ages 18 to 74 with Major Depressive Disorder and moderate-to-severe anhedonia with inadequate response to current antidepressant therapy of SSRI or SNRI.
Additional Information:
Subjects who complete this study may be eligible to enter in a yearlong open-label study of Aticaprant in addition to SSRI/SNRI.
iRx Reminder Data Gathering Study for Tardive Dyskinesia
Diagnosis: Patients with and without Tardive Dykinesia
Purpose: iRx Reminder has partnered with Videra to build an AI system that can detect Tardive Dyskinesia (TD) from home.
General Inclusion Criteria:
Female or male ages 18 and up who have been taking an antipsychotic for at least 90 days. Patients cannot have suffered moderate to severe head injury in the last year, have a learning disorder or developmental disorder that would inhibit their ability to complete the protocol and or severe visual impairment that cannot be corrected by glasses or contacts.
Additional Information:
We are asking patients with and without TD to come onsite and complete the Abnormal Involuntary Movement Scale (AIMS).
Vanda Pharmaceuticals Adolescent Schizophrenia or Bipolar I Study
Diagnosis: Schizophrenia or Bipolar I
Purpose: An open label, yearlong study in the safety and tolerability of flexible dosing of iloperidone in adolescent patients.
General Inclusion Criteria:
Females or males ages 12-17 diagnosed with Schizophrenia or Bipolar I who qualify for a change in antipsychotic treatment. The patient must be symptomatically stable and cannot have been hospitalized for psychiatric illness in the last 2 months prior to entry to the study.
Additional Information: Iloperidone (also known as FANAPT®) is an FDA approved medication for the treatment of schizophrenia in adults.
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:
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Taking an active role in your own treatment.
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The opportunity to receive treatments not otherwise available.
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Receiving skilled medical care at no financial cost.
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The opportunity to contribute to the current state of medical knowledge.
Resources
The following links to online resources may be helpful to you in gathering information about mental illnesses and alcohol or drug dependency. Charak Clinical Research Center is not affiliated with any of these organizations and is not responsible for the information and content found on the web sites included here.
The National Institute of Mental Health (NIMH) describes itself as “the largest scientific organization in the world dedicated to research focused on the understanding, treatment and prevention of mental disorders and the promotion of mental health.” The NIMH web site includes significant information about many behavioral health topics.
The National Alliance for the Mentally Ill (NAMI) has several chapters in Ohio and its web site includes local chapter information and programs as well as publications that may be downloaded at no cost. NAMI’s mission is “to improve the quality of life, ensure dignity and respect for persons with serous mental illness, and to support their families.”
Ohio NAMI: www.namiohio.org
National NAMI: www.nami.org
The Depression and Bipolar Support Alliance (DBSA) is a national patient-directed organization focusing on the most prevalent mental illnesses, according to its web site. The web site includes information regarding signs and symptoms, recovery, and information to assist families and friends of individuals affected by illnesses, particularly major depressive disorder and bipolar disorder.
The National Institute on Drug Abuse’s (NIDA) mission is “to lead the Nation in bringing the power of science to bear on drug abuse and addiction.” Two sections of the NIDA web site, “Parents & Teachers,” and “Students & Young Adults,” accessed through the top menu include topics that are particularly helpful to the general public.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides leadership in the national effort to reduce alcohol-related problems by conducting and supporting research of its own and other research institutes and government agencies; supporting the programs and work of agencies and organizations engaged in alcohol-related work; and translating and communicating research results to the public, health care professionals and policy makers. The Publications section of the web site includes information that is helpful to the general public.
The U.S. Department of Health and Human Services also sponsors the SAMHSA's National Clearinghouse for Alcohol and Drug Information (NCADI), a web site described as “the Nation's one-stop resource for information about substance abuse prevention and addiction treatment.”
Addiction Center was founded by recovering addicts and health information writers. Their goal is to provide the most up-to-date information on addiction. Addiction Center is owned and funded by Recovery Worldwide LLC, an organization that creates informational web properties on health and mental health-related topics.
Contact & Location
Charak Clinical Research Center
12395 McCracken Rd. Suite E
Garfield Heights, OH 44125
Phone - 877.4NEWMED
877.463.9633
Fax - 216.662.0469