Clinical Research


Hightop Health conducts ongoing proprietary clinical research to help develop cutting-edge treatments and deliver transformative mental health care for the most complex mental health conditions.

ONGOING RESEARCH

Groundbreaking Clinical Studies

Hightop Health’s clinical research program is dedicated to advancing mental health treatments through rigorous clinical trials. By participating in cutting-edge research, we develop and refine innovative therapies tailored to individual needs. For over 20 years, our clinical trials have helped develop the latest treatment options for various mental health conditions, ensuring the highest standards of care and driving continual improvements in the future of mental health care.

 

 

WHAT TO EXPECT

Participating In Clinical Trials

Hightop Health uses the following approach to provide groundbreaking research. Fill out our Contact Us form today to see if you qualify, or for more details.

 

 

1

TRIAL PARTICIPANTS

We conduct clinical studies in adults, including individuals over 65.

 

 

2

STUDY VISITS

Study visits may include routine blood work, a blood pressure check, an electrocardiogram (ECG), a physical exam, and a review of your illness, using both psychological measurement assessments as well as interviews, with our trained clinicians.

 

 

3

CURRENT STUDIES

We conduct ongoing clinical research trials about mental health conditions, including mood and anxiety disorders, bipolar or manic-depression, and attention deficit disorders.

 

 

INNOVATIVE CLINICAL RESEARCH

Clinical Research Center Of Excellence

As part of our mission to lead the way in mental health care, we established a longstanding proprietary and cutting-edge clinical research program. We conduct ongoing trials to arrive at life-changing treatments for future patients. Through rigorous clinical trials, we explore new therapeutic options and refine existing ones so future patients receive the most effective care available.

At Hightop Health, research is deeply engrained in our clinical philosophy. Alongside our ability to leverage learnings from involvement in sponsor-led clinical trials, we also conduct academic-based internal research to inform our clinical protocols, drive evidence-based strategies, and support further exploration of advancements in the field of mental health.

 

Our clinical research is developed and conducted in-house by our team of expert clinicians and researchers, led by Psych Atlanta’s Medical Director, Michael Banov, MD, who is board-certified in adolescent, addiction, and adult psychiatry and is a board-certified clinical investigator.

Our integrated clinical outcome measurement program in which all patients participate is led by Philip D. Harvey, PhD, Professor of Psychiatry at the University of Miami Miller School of Medicine.

 

GET ANSWERS

Frequently Asked Questions

Find answers to commonly asked questions about Hightop Health’s proprietary clinical research and learn more about participating in an ongoing trial.

 

 

We conduct ongoing clinical research trials for innovative treatments of various mental health illnesses, including mood and anxiety disorders, bipolar or manic depression, schizophrenia, and attention deficit disorders. Most of our clinical studies involve investigational medication and are approved by relevant Institutional Review Boards to ensure that they are conducted appropriately and with patient safety in mind.

Study visits may include routine blood work, blood pressure checks, electrocardiograms (ECGs), physical exams, and review of a patient’s symptoms and functionality with our trained clinicians. These assessments are typically covered by the pharmaceutical company sponsoring the trial.

Participants may also receive compensation for time and travel for some studies.

 

Most of our studies are conducted to determine the medication’s efficacy compared to a placebo. Clinical trial participants have the opportunity to become partners in scientific discovery, contributing to helping future generations lead healthier lives with newly discovered treatment options. We believe major medical breakthroughs could not happen without the generosity of clinical trial participants, young and old.

 

Current studies include:

  • Adult Attention-Deficit/Hyperactivity Disorder — Axsome Therapeutics
  • Binge Eating Disorder — Axsome Therapeutics
  • Bipolar Depression Vagal Nerve Stimulation — LivaNova
  • Major Depressive Disorder (Observational, Non-Interventional) — Janssen Pharmaceuticals
  • Major Depressive Disorder — Neumora Therapeutic
  • Major Depressive Disorder — Otsuka Pharmaceutical
  • Schizophrenia — Karuna Therapeutics
  • Treatment-Resistant Depression — Clexio Biosciences
  • Treatment-Resistant Depression (Psilocybin Treatment) — Compass Pathways
  • Postpartum Depression — Reunion Neuroscience

 

Currently, Hightop Health is only conducting clinical research in the Atlanta area. Patients looking to participate in a clinical research trial should fill out our Contact Us form.

 

 

Current & Upcoming Clinical Research

Stay updated on the latest and upcoming clinical research studies, offering the most current details on clinical trials and ongoing studies. For more information, or if you’re interested in participating, please email clinicaltrials@hightophealth.com  or call 770-422-2846.

Binge Eating Disorder — Axsome Therapeutics

Axsome Therapeutics is sponsoring a Phase 3 clinical trial for individuals with binge eating disorder (BED). This is a multi-center, double-blind, placebo-controlled study to assess the efficacy and safety of solriamfetol for the treatment of BED in adults, ages 18 – 55.

 

 

Treatment-Resistant Depression (Psilocybin Treatment) — Compass Pathways

Compass Pathways is conducting a three-part, Phase 3, randomized clinical trial using COMP360, which is a synthetic form of psilocybin, given with psychological support. This trial is double-blind, placebo-controlled, and looks at the effects of COMP360 as a single administration for treatment in treatment-resistant depression (TRD). Opportunities for additional treatment sessions are available throughout the study.

Major Depressive Disorder (Observational, Non-Interventional)

Psych Atlanta is conducting a non-interventional, observational, 12-month study. Participants must have a diagnosis of Major Depressive Disorder (MDD), without any psychotic features, and must currently be on a medication for depression.

Treatment-Resistant Depression (TRD) — Clexio Biosciences

In this research study, Clexio Biosciences will be evaluating a drug called CLE-100 for individuals diagnosed with major depressive disorder (MDD). If eligible, you will be randomly assigned to either receive the study drug or placebo (no active ingre­dients) in a four-week study. After that period, participants will be offered to receive the active study drug for a six-month period.

Major Depressive Disorder — Juniper

Otsuka Pharmaceutical Development & Commercialization, Inc. is conducting a research study for adults with major depressive disorder (MDD). Eligible participants include those from 18 to 65 years old, have been diagnosed with major depression by your healthcare provider, and have not responded to at least one (but no more than three) treatment options for depression.

 

 

Postpartum Depression — Reunion Neuroscience

Reunion Neuroscience is conducting a Phase 2, randomized, double-blind, dose-controlled study evaluating the effectiveness of the study drug RE104, which is a subcutaneous injection that will require observation after administration. This trial focuses on individuals with postpartum depression.

quotes

“At Hightop Health, we believe that the most effective and reliable psychopharmacology research is conducted in real clinical settings by practicing psychiatrists with extensive clinical trial expertise.”

– Michael Banov, MD

Medical Director, Psych Atlanta

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