Clinical Research

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.

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TRIAL PARTICIPANTS

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

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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.

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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.

What does participating in a clinical research trial involve?

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.

What is the clinical research from your trials used for?

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.

What current studies are you conducting?

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

How do I get involved in clinical research?

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

Info to be included here regarding clinical trials and contacting someone if interested in participating.

Adult ADHD — Axsome Therapeutics

Axsome Therapeutics is producing a Phase 3 clinical study which focuses on individuals diagnosed with attention-deficit/hyperactivity disorder (ADHD) who are currently not on any medications. This is a multi-center, double-blinded and placebo-controlled trial to assess the efficacy and safety of sunosi (solriamfetol) in adults with ADHD, ages 18 – 55.

Bipolar Depression Vagal Nerve Stimulation — LivaNova

LivaNova is conducting a five-year, placebo-controlled trial evaluating the effectiveness of vagal nerve stimulation (VNS) in individuals with bipolar depression. This is a device study which is implanted intravenously and requires a one-day minor outpatient surgical procedure.

Major Depressive Disorder — Neumora Therapeutics

Neumora Therapeutics is conducting a Phase 3, randomized, double-blind, and placebo-controlled trial to study the effects of an oral NMRA – 335140 tablet. Participants must have a diagnosis of major depressive disorder (MDD). This study also has an Open Label Extension for qualifying participants.

Schizophrenia — Karuna Therapeutics

Karuna Therapeutics is conducting a Phase 3, randomized, double-blind, placebo-controlled, outpatient trial focusing on individuals with schizophrenia, who have a history of inadequate response to their current atypical antipsychotic treatment/medication. This study also has an Open Label Extension for any qualifying participants.

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 psilocybin. 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).

Binge Eating Disorder — Axsome Therapeutics

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

Major Depressive Disorder (Observational, Non-Interventional) — Janssen Pharmaceuticals

Janssen Pharmaceuticals 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 be currently on a stable medication.

Major Depressive Disorder — Otsuka Pharmaceutical

Otsuka Pharmaceutical is conducting a Phase 2 clinical trial for those diagnosed with major depressive disorder (MDD). This trial will assess the efficacy, tolerability, and safety of centanafadine. This study is randomized, double-blinded, placebo-controlled, and the medication is an extended-release capsule.

Treatment-Resistant Depression (TRD) — Clexio Biosciences

Clexio Biosciences is producing a Phase 2 clinical trial for individuals with a diagnosis of major depressive disorder (MDD) or treatment-resistant depression (TRD). The trial uses an oral ketamine tablet, has a possibility of placebo, is randomized, and is double-blind. Qualifying participants may have the option to join the Open Label Extension.

upcoming

Postpartum Depression — Reunion Neurosciences

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

ONGOING RESEARCH

Groundbreaking Clinical Studies

WHAT TO EXPECT

Participating in Clinical Trials

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2

3

INNOVATIVE CLINICAL RESEARCH

Clinical Research Center Of Excellence

GET ANSWERS

Frequently Asked Questions

Current & Upcoming Clinical Research

upcoming

“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

Learn More or Apply to Be Part of an Upcoming Study

Clinical Research

ONGOING RESEARCH

Groundbreaking Clinical Studies

WHAT TO EXPECT

Participating in Clinical Trials

1

2

3

INNOVATIVE CLINICAL RESEARCH

Clinical Research Center Of Excellence

GET ANSWERS

Frequently Asked Questions

Current & Upcoming Clinical Research

upcoming

“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

Learn More or Apply to Be Part of an Upcoming Study

“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