Clinical Trials
The Department of Psychiatry conducts clinical trials to explore new treatments for various disorders, including anxiety, depression, bipolar disorder, and schizophrenia.
Assessments and treatments are provided at no cost. Participants are compensated for their time.
For more information call 614-293-7109 or email: Clinicaltrials@osumc.edu.
Currently enrolling studies
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 as an Adjunct to Antidepressant Therapies in the Treatment of Subjects With Generalized Anxiety Disorder Who Have Had an Inadequate Response to Antidepressant Therapies
Description of Study: A 6-week study to evaluate the efficacy of ABBV-932 added to the antidepressant therapies (ADTs) in adult participants with GAD who have had an inadequate response ADTs.
Eligibility Criteria
- Adults 18-65
- Diagnosed with GAD
- No depressive episodes in at least 6 months
- Currently receiving treatment of either paroxetine, escitalopram, duloxetine, or venlafaxine ER
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: Abbvie Inc
Source: https://clinicaltrials.gov/study/NCT06846320?term=M25-099&rank=1
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as Monotherapy Treatment in Patients with Generalized Anxiety Disorder Who Have Had Inadequate Response to Generalized Anxiety Disorder Treatment
Description of Study: A 6-week study to evaluate the efficacy of 2 doses of ITI-1284 in adult participants with Generalized Anxiety Disorder (GAD) who have had inadequate response to GAD treatment (paroxetine, venlafaxine XR, duloxetine, escitalopram, and buspirone).
Eligibility Criteria
- Adults 18-65
- Diagnosed with GAD
- No depressive episodes in at least 6 months
- Have received treatment of paroxetine, escitalopram, duloxetine, venlafaxine XR, or buspirone
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: Intra-Cellular Therapies, Inc.
Multicenter, Open-label Study to Evaluate the Long-term Safety and Tolerability of ABBV-932 in Subjects with Depressive Episodes Associated with Bipolar I or II Disorder
Description of Study: A 26-week study to evaluate the long-term safety and tolerability of ABBV-932 in the treatment of subjects with depressive episodes associated with bipolar I or II disorder.
Eligibility Criteria
- Adults 18-64
- Diagnosed with Bipolar Disorder I or II
- Currently in a depressive episode
- Not currently receiving treatment
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: Abbvie Inc
A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms
Description of Study: Part 1 is a 6-week study to assess the efficacy of seltorexant, compared to placebo, administered with a current SSRI/SNRI in adult participants with MDD (Major Depressive Disorder) with symptoms of insomnia. In Part 2 open-label phases, all participants will receive seltorexant orally in addition to their background SSRI/SNRI treatment.
Eligibility Criteria
- Adults 18 to 74
- Diagnosed with MDD
- Currently in a depressive episode
- Current taking SSRI/ SNRI treatment
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: Janssen Research & Development, LLC
A Randomized, Double-blind, Multicenter, Placebo-controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-89495120 as Monotherapy in Adult Participants With Major Depressive Disorder (MDD)
Description of Study: A study to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (MDD).
Eligibility Criteria
- Adults 18 to 64
- Diagnosed with MDD
- Currently in a depressive episode, with at least one episode prior
- Have tried at least 1 antidepressant before
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: Janssen Research & Development, LLC
Source: https://clinicaltrials.gov/study/NCT06785012#participation-criteria
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER) A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate
Description of Study: A study to evaluate the efficacy of Vagus Nerve Stimulation (VNS) on symptoms of depression in participants with bipolar disorder in a major depressive episode.
Eligibility Criteria
- Adults 18 and older
- Diagnosed with Bipolar Disorder I or II
- Currently in a depressive episode
- Failed four prior antidepressant treatments
Principal Investigator: Kevin Reeves, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: LivaNova
Source: https://classic.clinicaltrials.gov/ct2/show/NCT03887715
A Phase 2, Multicenter, 6-Week, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects with Bipolar Depression
Description of Study: A 6-week study evaluate the safety and efficacy of icalcaprant compared to placebo in the treatment of subjects with bipolar I or II disorder who are currently experiencing a major depressive episode (MDE) and currently on a mood stabilizer (valproate, lithium, or lamotrigine).
Eligibility Criteria
- Adults 18-65
- Diagnosed with Bipolar Disorder I or II
- Currently in a depressive episode
- Currently receiving treatment of a mood stabilizer
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: Abbvie Inc
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
Description of Study: This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major Depressive disorder (TRD) and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.
Eligibility Criteria
- Adults 18 to 65
- Diagnosed with TRD
- Currently in a major depressive episode
- No or little response to at least 2 antidepressants
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: atai Therapeutics Inc.
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
A 6-week study to evaluate the efficacy of Lumateperone compared to placebo used in addition to oral antidepressants in adults with MDD. A 6-week study to evaluate the efficacy of Lumateperone compared to placebo used in addition to oral antidepressants in adults with MDD.
Eligibility Criteria:
- Adults 18-65
- Diagnosed with MDD
- Current major depressive episode
- Inadequate response to current antidepressant therapy
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact:
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: Intra-Cellular Therapies, Inc.
Source: https://classic.clinicaltrials.gov/ct2/show/NCT05850689
A Phase 2, Multicenter, 6-Week, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects with Major Depressive Disorder
Description of Study: A 6-week study to evaluate the safety and efficacy of icalcaprant in the treatment of subjects with major depressive disorder (MDD) who are currently experiencing a major depressive episode.
Eligibility Criteria:
- Adults 18-65
- Diagnosed with MDD
- Current major depressive episode
- Willing to discontinue antidepressant treatments
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact:
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: Abbvie Inc
Source: https://clinicaltrials.gov/study/NCT07276997?term=m25-987&rank=1
A Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients with Cancer and Other Medical Illnesses
Description of Study: A 6-week study to evaluate the effect of 30 mg RE104 on depressive symptoms in participants with adjustment disorder (AjD) compared to 1.5 mg RE104.
Eligibility Criteria:
- Adults 18-80
- Depression due to cancer, Parkinson’s, ALS, MS, or IPF
- Currently depressed
- Projected life expectancy of ≥6 months.
Principal Investigator: Subhdeep Virk, MD
Contact:
Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu
Funding/Study Sponsor: Reunion Neuroscience