Psychiatry & Behavioral Health Clinical Trials I Ohio State College of Medicine

Clinical Trials

The Department of Psychiatry conducts clinical trials to explore new treatments for various disorders, including 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

Adult Bipolar Study – Protocol 55308942BIP2001
A Study of JNJ-55308942 in the Treatment of Bipolar Depression

Description of Study: A 6-week study to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder in a major depressive episode.

Eligibility Criteria:
- Adults 18-64
- Diagnosed with Bipolar Disorder I or II
- Currently in a depressive episode
- 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://classic.clinicaltrials.gov/ct2/show/NCT05328297
Adult Bipolar Study – Protocol LND300
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)

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
Adult Depression Study – Protocol 1402-0011
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People with Depression

Description of Study: A 6-week study to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Participants continue their standard antidepressant therapy throughout the study.

Eligibility Criteria:
- Adults 18–65
- Diagnosed with MDD
- 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: Boehringer Ingelheim

Source: https://classic.clinicaltrials.gov/ct2/show/NCT04521478
Adult Depression Study – Protocol NBI-1065845-MDD2024
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults with Major Depressive Disorder (MDD) (SAVITRI)

Description of Study: An 8-week study to evaluate the efficacy of NBI-1065845 compared with placebo used in addition to oral antidepressants in adults with MDD on improving symptoms of depression.

Eligibility Criteria:
- Adults 18-65
- Diagnosed with MDD
- 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: Neurocrine Biosciences

Source: https://clinicaltrials.gov/ct2/show/NCT05203341
Adult Depression Study – Protocol 382-201-00001
A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults with Major Depressive Disorder

Description of Study: An 14-week study to evaluate the efficacy of SEP-363856 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 must be at least 8 weeks
- 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: Otsuka Pharmaceutical Development & Commercialization, Inc.

Source: https://classic.clinicaltrials.gov/ct2/show/NCT05593029
Adult Depression Study – Protocol 67953964MDD3002
A Study of Aticaprant 10 Milligrams (mg) as Adjunctive Therapy in Adult Participants with MDD With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy (VENTURA-2)

Description of Study: A 7-week study to evaluate the efficacy of aticaprant compared with placebo used in addition to a SSRI or SNRI in adults with MDD who have a loss of interest and/or enjoyment as one of their symptoms of depression.

Option to continue taking Aticaprant for up to one year after the end of the randomized study.

Eligibility Criteria:
- Adults 18-74
- Diagnosed with MDD
- Inadequate response to current antidepressant therapy
- Currently in a major depressive episode
- 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://classic.clinicaltrials.gov/ct2/show/NCT05550532
Adult Depression Study – Protocol DB104-01
A Biomarker-Guided, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients with Treatment Resistant Depression (ENLIGHTEN)

Description of Study: A 6-week study to evaluate the efficacy of liafensine compared with placebo in adults with MDD.

Eligibility Criteria:
- Adults 18-70
- Diagnosed with MDD
- Inadequate response to at least 2 antidepressants in the past 5 years
- Currently in a major depressive episode
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD

Contact: Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu

Funding/Study Sponsor: Denovo Biopharma LLC

Source: https://classic.clinicaltrials.gov/ct2/show/NCT05113771
Adult Depression Study – Protocol COMP006
Efficacy, Safety, and Tolerability of Administrations of COMP360 in Participants with TRD (treatment-resistant depression)

Description of Study: A 52-week study to assess the efficacy of COMP360 (psilocybin), administered with psychological support in adult participants with TRD (treatment resistant depression), in improving symptoms of depression.

Eligibility Criteria:
- Adults 18 and older
- Diagnosed with TRD
- Currently in a major depressive episode
- Otherwise medically stable
Principal Investigator: Subhdeep Virk, MD

Contact: Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu

Funding/Study Sponsor: COMPASS Pathways

Source: https://classic.clinicaltrials.gov/ct2/show/NCT05624268
Adult Depression Study – Protocol ITI-007-505
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 18-65
- 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
Adult Schizophrenia Study – Protocol CT-155-R-001
Exploratory Study of the Digital Therapeutics CT-155 in the Treatment of People with Schizophrenia

Description of Study: A 7-week study to evaluate an interactive, app-based intervention (CT-155) to treat some symptoms of schizophrenia.

Eligibility Criteria:
- Adults 18-64
- Diagnosed with schizophrenia
- Taking a stable dose of antipsychotic medications
- Is the sole user of an iPhone or Android cellphone
Principal Investigator: Walter Stearns, MD

Contact: Phone: 614-293-7109
Email: Clinicaltrials@osumc.edu

Funding/Study Sponsor: Click Therapeutics, Inc. and Boehringer Ingelheim

Source: https://classic.clinicaltrials.gov/ct2/show/NCT05438160

Psychiatry and Behavioral Health Clinical Trials

Clinical Trials

Currently enrolling studies

Adult Bipolar Study – Protocol 55308942BIP2001

Adult Bipolar Study – Protocol LND300

Adult Depression Study – Protocol 1402-0011

Adult Depression Study – Protocol NBI-1065845-MDD2024

Adult Depression Study – Protocol 382-201-00001

Adult Depression Study – Protocol 67953964MDD3002

Adult Depression Study – Protocol DB104-01

Adult Depression Study – Protocol COMP006

Adult Depression Study – Protocol ITI-007-505

Adult Schizophrenia Study – Protocol CT-155-R-001

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