The Clinical Trials Unit

The Clinical Trials Unit offers children, adolescents, and adults diagnosed with a wide range of psychiatric disorders an opportunity to participate in innovative research and clinical trials.

Our team of experienced psychiatrists and clinicians promotes excellence in clinical care through cutting edge research on the latest medications and novel therapeutic options in hopes of improving patient outcomes and quality of life.


Staff | Overview | Participate in a Clinical Trial | Active Clinical Trials | Upcoming


Current Staff

  • Director: Dr. Mirjana Domakonda, M.D.
  • Senior Research Director: Dr. Andrew Winokur, MD, PhD
  • Clinical Trials Unit Supervisor: Valerie Salerno, RN, BS
  • Clinical Research Associate: Ania Poltorak, MA, LPC
  • Clinical Research Assistant: Shaylee King, MS
  • Research Assistant: Bryce Hill, BS
  • Investigator: Dr. Sudeshna Basu, MD
  • Investigator: Dr. David Pepper, MD
  • Investigator: Dr. Benjamin Anderson, MD

Overview

Psychiatric clinical trials are highly regulated research studies using human volunteers to test the safety and efficacy of novel psychiatric drugs and treatments. Clinical trials are essential for developing new methods to prevent, diagnose, and treat psychiatric disorders. By participating in a clinical trial, patients can take an active role in managing their symptoms, gain access to novel research treatments before they are widely available, and help others by advancing our scientific understanding of the causes and contributors of psychiatric conditions.

CLINICAL TRIALS UNIT

The Clinical Trials Unit is located on the Hartford Hospital / Institute of Living campus in Hartford, CT. The service, directed by Drs. Mirjana Domakonda and Andrew Winokur, conducts controlled, clinical testing in human subjects of investigational psychiatric drugs, therapeutic modalities, or combined treatments that are currently in development but not yet approved for use in routine clinical care. Investigational drugs and/or treatments can only be administered to eligible individuals who are enrolled in a formal research study.

All research and clinical studies at the Clinical Trials Unit are conducted under investigator-initiated or industry-sponsored protocols with financial support from pharmaceutical companies, government agencies, and/or non-profit entities. The Hartford Healthcare Institutional Review Board, in conjunction with study sponsors and regulatory authorities, reviews, approves, and oversees all research and clinical trials at the Clinical Trials Unit.

Below you can find more information about currently running research and clinical trials and participant eligibility criteria. If you or a loved one are interested in participating in a research or clinical trial, please contact Ania Poltorak at 860-545-7265.


Participate in a Clinical Trial

COVID-19 Update: In an effort to protect the health and safety of our staff and study participants, the Clinical Trials Unit has temporarily suspended all in person recruitment due to COVID 19. We are still conducting phone screens of potential participants.

Our current and upcoming studies are listed below. For more information or to see if you or your loved one are eligible to participate in an ongoing or upcoming study, please email us at clinical.trials@hhchealth.org or call us 860-545-7476. We look forward to hearing from you.


Active Clinical Trials

Now Recruiting

MAJOR DEPRESSIVE DISORDER

ESKETINSUI2002 (Janssen) CURRENTLY RECRUITING PARTICIPANTS
Clinical trial to examine the efficacy and safety of an investigational medication - esketamine (given as a nasal spray) - in adolescents hospitalized with depression and suicidal ideation.

Qualified participants include:

  • Adolescents aged 12 to 17 years old
  • Have a diagnosis of major depressive disorder and are currently experiencing suicidal ideation
  • Currently prescribed or willing to switch to a study-approved antidepressant

Those that qualify will: 

  • Receive study-related care with a board-certified child and adolescent psychiatrist and other clinical staff at no cost
  • Receive reimbursement for study-related travel costs

Contact Ania Poltorak at 860-545-7265 or via email ania.poltorak@hhchealth.org

Now Recruiting

BORDERLINE PESONALITY DISORDER

331-201-00242 (Otsuka) CURRENTLY RECRUITING PARTICIPANTS
Clinical trial to examine the efficacy and safety of brexpiprazole in patients with borderline personality disorder.

Qualified participants include:

  • Adults aged 18 to 65 years old
  • Have been diagnosed with borderline personality disorder

Those that qualify will:

  • Receive study drug and study-related care with a board-certified psychiatrist and other clinical staff at no cost. 
  • Receive reimbursement for study participation and costs.
  • Following the 12-week study, eligible/interested participants may choose to participate in an open-label extension study (331-201-00195, Otsuka).

Contact Ania Poltorak at 860-545-7265 or via email ania.poltorak@hhchealth.org

Now Recruiting

POST-TRAUMATIC STRESS DISORDER (PTSD)

331-201-00071 (Otsuka) CURRENTLY RECRUITING PARTICIPANTS
Clinical trial to examine the efficacy and safety of brexpriprazole combined with sertraline as treatment for adults with posttraumatic stress disorder.

Qualified participants include:

  • Adults aged 18 to 65 years old
  • Have been diagnosed with posttraumatic stress disorder
  • Onset of symptoms for a minimum of 6 months prior to screening

Those that qualify will:

  • Receive study drug and study-related care with a board-certified psychiatrist and other clinical staff at no cost.
  • Receive reimbursement for study participation and costs.

For more information, contact Ania Poltorak at 860-545-7265 or via email ania.poltorak@hhchealth.org

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Upcoming Clinical Trials

Coming SoonMAJOR DEPRESSIVE DISORDER

1402-0011 (Boehringer-Ingelheim)
New upcoming multicenter, randomized, double-blind, double dummy, placebo controlled study investigating the efficacy of BI1358894 to evaluate safety and tolerability of the investigational medication in major depressive disorder.

Stay tuned for more details!

Coming Soon

TREATMENT RESISTANT DEPRESSION

54135419TRD4005 (Janssen)
A randomized, double blind, multicenter, placebo controlled study to evaluate safety and efficacy and tolerability of esketamine nasal spray administered as a monotherapy for adults with treatment resistant depression.

Stay tuned for more details!

Coming Soon

MAJOR DEPRESSIVE DISORDER

AGN-151607 (Allergan)
New upcoming multicenter, randomized, double blind study will be looking to enroll participants in to investigate the efficacy and safety of an investigational medication botulinum toxin type A compared with placebo in patients with symptoms of major depressive disorder.

Stay tuned for more details!

Coming Soon

BIPOLAR DISORDER

NRX-100-001 and NRX-100-002 (NeuroRx)
Clinical trial to examine the efficacy and safety of intravenous ketamine infusion in adults diagnosed with bipolar disorder with acute suicidal ideation who are in need of inpatient hospitalization for treatment and stabilization. Following inpatient hospitalization, eligible participants may have an opportunity to participate in an outpatient, extension study to determine the efficacy of an oral medication in reducing symptom severity and relapse.

For more information, contact Ania Poltorak at 860-545-7265 or via email ania.poltorak@hhchealth.org

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Contact the Clinical Trials Unit