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
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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 for anxiety
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.eduFunding/Study Sponsor: Abbvie Inc
Source: https://clinicaltrials.gov/study/NCT06846320?term=M25-099&rank=1
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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.eduFunding/Study Sponsor: Intra-Cellular Therapies, Inc.
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A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of Fixed Doses of SEP-363856 to Placebo in the Treatment of Adults with Generalized Anxiety Disorder
A Phase 3, Multicenter, Open-Label Extension Trial to Evaluate the safety and Tolerability of SEP-363856 in the Treatment of Adults with Generalized Anxiety Disorder
Description of Study: This trial is designed to compare the efficacy, safety and tolerability of fixed doses of SEP-363856 (50 and 75 mg/day) compared to placebo in adults with GAD for 8 weeks. Eligible participants can then receive SEP-363856 (50 and 75 mg/day) for 26 weeks.
Eligibility Criteria
- Adults 18+
- Diagnosed with GAD
- No depressive episodes in at least 12 months
- Willing to discontinue any current treatments
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.eduFunding/Study Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Source: https://clinicaltrials.gov/study/NCT07759128
https://clinicaltrials.gov/study/NCT07786454
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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.eduFunding/Study Sponsor: Abbvie Inc
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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.eduFunding/Study Sponsor: LivaNova
Source: https://classic.clinicaltrials.gov/ct2/show/NCT03887715
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A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment with Seltorexant
Description of Study: The purpose of this study is to help researchers understand if the investigational study medication seltorexant (JNJ-42847922) is safe and effective in treating participants with major depressive disorder (MDD). Participants in this study will be randomly assigned (50/50 chance) to receive either seltorexant or placebo in the first 6-week phase. Participants who complete the 6- week phase may be able to receive seltorexant for up to 6 months in the second phase without placebo.
Eligibility Criteria
- Adults 18 to 74
- Diagnosed with MDD
- Current major depressive episode
- Willing to discontinue any current treatments
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.eduFunding/Study Sponsor: Janssen Research & Development, LLC
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Fixed Doses of Lumateperone Administered as Monotherapy in Participants with Major Depressive Disorder and an Open label Long-term Extension Treatment with Lumateperone
Description of Study: In this trial, lumateperone is evaluated for efficacy, safety, and tolerability for participants with Major Depressive Disorder (MDD). For 6 weeks, eligible participants will receive either lumaterperone 42 mg/day, 21mg/day, or placebo. Following that period, participants may receive either lumaterperone 42 mg/day or 21 mg/day for an additional 24 weeks.
Eligibility Criteria
- Adults 18-74
- Diagnosed with MDD
- Current major depressive episode
- Willing to discontinue any current treatments
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.eduFunding/Study Sponsor: Intra-Cellular Therapies, Inc.
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A Study of Esketamine Nasal Spray as Monotherapy in Adult Participants with Treatment-resistant Depression
Description of Study: A 22-week study to evaluate how well each individual dose of esketamine (56 milligrams [mg] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder [MDD] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).
Eligibility Criteria
- Adults 18+
- Diagnosed with TRD
- Current major depressive episode
- No history of ketamine or esketamine
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact
Phone: 614-293-7109
Email: Clinicaltrials@osumc.eduFunding/Study Sponsor: Janssen Research & Development
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Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Description of Study: 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 to 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.eduFunding/Study Sponsor: Intra-Cellular Therapies, Inc.
Source: https://classic.clinicaltrials.gov/ct2/show/NCT05850689
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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.eduFunding/Study Sponsor: AbbVie Inc
Source: https://clinicaltrials.gov/study/NCT07276997?term=m25-987&rank=1
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A prospective, double-blind, randomized, multi-center, clinical investigation. Patients will be randomized to a treatment (active DBS) or control group (delayed-stimulation DBS).
Description of Study: A 3-year study to evaluate the effectiveness and safety of Deep Brain Stimulation (DBS) as an adjunctive treatment of Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to 4 or more antidepressant treatments. Half of the subjects will receive active DBS therapy, while half will receive sham stimulation. After 12-months, all subjects will receive active DBS therapy.
Eligibility Criteria:
- Adults 22-70
- Diagnosed with MDD
- Inadequate response to 4 or more antidepressants
- Current major depressive episode
- Otherwise medically stable
Principal Investigator: Kevin Reeves, MD
Contact:
Phone: 614-293-7109
Email: Clinicaltrials@osumc.eduFunding/Study Sponsor: Abbott Neuromodulation
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A phase 2b/3, multicenter, randomized, double-blind, controlled trial, with an open label extension, to investigate the efficacy, safety, and tolerability of COMP360 in participants with post-traumatic stress disorder.
Description of Study: A 62-week study to investigate the efficacy, safety, and tolerability of COMP360 in participants with post-traumatic stress disorder. Participants will receive either COMP360 25 mg, 10 mg, or 1 mg in a safe environment in the presence of a study support provider and study doctor.
Eligibility Criteria:
- Adults 18+
- Diagnosed with PTSD
- Willing to discontinue antidepressant treatments
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD
Contact:
Phone: 614-293-7109
Email: Clinicaltrials@osumc.eduFunding/Study Sponsor: Compass Pathfinder Limited
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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.eduFunding/Study Sponsor: Reunion Neuroscience, Inc.
Source: https://clinicaltrials.gov/study/NCT07002034