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.
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.
Current Clinical Trials
Charak Clinical Research Center is currently conducting clinical trials involving the following mental health diagnoses.
Otsuka Pharmaceuticals Adolescent Schizophrenia Study
Diagnosis: Schizophrenia
Purpose: A six week study of the safety and efficacy of brexpiprazole (Rexulti) compared to aripiprazole (Abilify) and placebo with adolescent patients diagnosed with schizophrenia
General Inclusion Criteria:
Male or female 13 to 17 years of age with a current primary diagnosis of schizophrenia and a history of the illness (diagnosis or symptoms) for at least six months prior to the Screen Visit
Generally in good physical health
No current substance abuse or dependence
Additional Information
Subjects who complete this study may be eligible to participate in a long-term, open-label, follow-up study of brexpiprazole without comparators (all participants will receive brexpiprazole) for up to 24 months
Call us at 877.463.9633 if you wish to take part
Papilion Monarch, Abilify MyCite Adult Schizophrenia Study
Diagnosis: Schizophrenia
Purpose: A study comparing the hospitalization rates of participants taking Abilify MyCite compared to their hospitalization rates while taking standard of care medications before entering the study
General Inclusion Criteria:
Male or female 18 to 65 years of age
Primary diagnosis of Schizophrenia with one or more hospitalizations for schizophrenia in the 48 months prior to the Screen Visit and been prescribed oral antipsychotic treatment for 6 months or longer prior to the Screen Visit
Participants must possess a cell phone and be familiar with its use and be willing to download and interact with the Abilify MyCite App and adequately operate all study related devices and complete all study related tasks
Generally in good physical health
No substance abuse or dependence for the previous 12 months
Additional information:
Abilify MyCite is a tablet of aripiprazole with an IEM (Ingestible Event Marker) sensor embedded in it. This is the study medication that all study participants will take.
Study participants must wear an Abilify MyCite Patch (a wearable sensor) that detects the signal from the IEM sensor after the tablet has been ingested and transmits data to a smart phone
Abilify MyCite App is a smartphone app used with a compatible smart phone to display medication ingestion information for the participant
There is also a web-based portal or dashboard for investigators and study particpants’ caregivers
Call us at 877.463.9633 if you wish to take part
Teva Adult & Adolescent Schizophrenia Study
Diagnosis: Schizophrenia
Purpose: A long-term study to evaluate the safety, tolerability & efficacy of risperidone extended-release subcutaneous injectable suspension (TV-46000) compared to placebo and administered either once each month or once every two months to adolescent patients diagnosed with schizophrenia
General Inclusion Criteria:
Male or female 13 to 17 years of age
Diagnosis of Schizophrenia for more than 12 months and one or more episodes of relapse in the 24 months prior to the Screen Visit
Generally in good physical health
No current substance abuse or dependence
A parent/caregiver must accompany the participant to each visit and be available to provide reliable information regarding the participant’s ongoing condition
Additional Information:
The study consists of four phases
Phase I) A Screening Phase to confirm the participant is appropriate for the study. Up to 4 weeks in length
Phase II) A Conversion / Stabilization Phase during which participants not currently taking oral risperidone will be converted from their current antipsychotic medication to oral risperidone. 12 weeks in length
Phase III) An Active-treatment Phase during which participants receive monthly or bimonthly injections of either risperidone or placebo. This phase is conducted in a double-blinded manner wherein participants and study staff do not know which product the participant is receiving. Up to 56 weeks in length.
Phase IV) Follow-up Phase to monitor the participant’s return to non-study medication. 4 weeks in length.
Call us at 877.463.9633 if you wish to take part
