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.

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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.

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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.

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

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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

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Call us at 877.463.9633 if you wish to take part

Livanova Treatment Resistant Major Depressive Disorder Study

Diagnosis: Treatment Resistant Major Depressive Disorder

Purpose: A long term study of the safety & efficacy of VNS (Vagus Nerve Stimulation) as adjunctive therapy for individuals diagnosed with Treatment Resistant Major Depressive Disorder compared to a no-stimulation control group

General Inclusion Criteria:

Male or female 18 years of age or older

Primary diagnosis of Treatment-resistant Major Depressive Disorder

During their current major 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 dependence 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

Indivior Opioid Use Disorder Study

Diagnosis: Moderate to Severe Opioid Use Disorder

Purpose: A study comparing the efficacy of 100-mg and 300-mg maintenance doses of Buprenorphine extended-release subcutaneous injection (SUBLOCADE) in treatment-seeking adults with Opioid Use Disorder and high-risk opioid use

General Inclusion Criteria:

Male or female 18 years of age and older

Primary diagnosis of Opioid Use Disorder and:

Using opioids via injection for an average of 5 or more days per week for at least 4 weeks prior to the Screen Visit

or

Using at least 500mg intravenous heroin equivalent or highly potent synthetic opioids for 5 or more days per week for at least 4 weeks prior to the Screen Visit

Additional Information:

All eligible study participants who choose to enter the study will initially receive two 300mg doses of SUBLOCADE via subcutaneous injection one week apart.

These will then be followed by up to 8 additional subcutaneous injections of either 100mg or 300mg doses of SUBLOCADE given once every 4 weeks.

Study participants will be required to attend weekly visits to the research site for the first ten weeks of participation in the study. These visits are designed to allow for the monitoring of participants’ health and wellbeing.

The frequency of the site visits changes to every two weeks from week 10 through the end of study participation.  

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