Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients with Major Depressive Disorder (MDD) who have had an Inadequate Response to Antidepressants Alone  

Description of Study: This is an approximately eight-week study to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy in patients with MDD who have had an inadequate response to antidepressants alone.

Eligibility Criteria

• Adults 18–65 diagnosed with MDD (otherwise medically stable)
• Inadequate response to current antidepressant therapy

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

Funding/Study Sponsor: Allergan

Source: https://clinicaltrials.gov/ct2/show/NCT03738215?term=3111-301-001&rank=1

A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression  

Description of Study: This 11-week study evaluates the efficacy of JNJ-67953964 as adjunctive treatment in participants with major depressive disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment.

Eligibility Criteria

• Adults 18–64 diagnosed with MDD (otherwise medically stable)
• Currently treated with SSRI or SRNI for at least six weeks but no more than 12 months

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/ct2/show/NCT03559192?term=MDD2001&rank=2

A Trial to Evaluate the Efficacy, Safety and Tolerability of Brexpiprazole in the Maintenance Treatment of Adults with Major Depressive Disorder 

 Description of Study: This study can last up to one year and will assess the safety, efficacy and tolerability of brexpiprazole as adjunctive therapy to protocol-specific open-label antidepressant therapy.

Eligibility Criteria

• Adults 18–65 diagnosed with recurrent MDD (otherwise medically stable)
• Inadequate response to one or two adequate antidepressant treatments

Principal Investigator: Subhdeep Virk, MD

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

 Funding/Study Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Source:https://clinicaltrials.gov/ct2/show/NCT03538691?term=331-201-00079&rank=1

A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, with or without Mixed Features 

 Description of Study: This study can last up to 52 weeks and will evaluate the efficacy and safety of cariprazine in prevention of relapse in patients with bipolar I disorder whose current episode is manic or depressive, with or without mixed features.

Eligibility Criteria

• Adults 18–65 diagnosed with bipolar I disorder (otherwise medically stable)
• Currently experiencing mania or depression

Principal Investigator: Subhdeep Virk, MD

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

Funding/Study Sponsor: Allergan

Source: https://clinicaltrials.gov/ct2/show/NCT03573297?term=RGH-MD-25&rank=1

Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients with Schizophrenia 

Description of Study: This study can last up to 44 weeks. The purpose of this study is to evaluate the efficacy and safety of cariprazine in the prevention of relapse in patients with schizophrenia.

Eligibility Criteria

• Adults 18–64 diagnosed with schizophrenia (otherwise medically stable)
• Currently experiencing symptoms

Principal Investigator: Subhdeep Virk, MD

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

Funding/Study Sponsor: Allergan

Source: https://clinicaltrials.gov/ct2/show/NCT03593213?term=RGH-MD-24&rank=1

Efficacy, Safety and Tolerability of Levomilnacipran ER in Pediatric (ages seven to 17) with Major Depressive Disorder

Description of Study: This study lasts approximately 10 weeks and will evaluate levomilnacipran in children and adolescents (ages seven to 17) with depression.

Eligibility Criteria

• Children ages seven to 17 with symptoms of depression (otherwise medically stable)

Principal Investigator: Amy Stabile, MD

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

Funding/Study Sponsor: Allergan

Source: https://clinicaltrials.gov/ct2/show/NCT03569475?term=LVM-MD-14&rank=1

Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents with Bipolar I Disorder

Description of Studies

A1281198: This is a four-week double-blind, randomized, placebo controlled study to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

A2181201: This is a six-month, open label extension study for participants of the A1281198 study.

Eligibility Criteria

• Children ages 10–17 with symptoms of bipolar I disorder (otherwise medically stable)

Principal Investigator: Ghada Lteif, MD

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

Funding/Study Sponsor: Pfizer

Source
https://clinicaltrials.gov/ct2/show/NCT02075047?term=A1281198&rank=2
https://clinicaltrials.gov/ct2/show/NCT03768726?term=A1281198&rank=1

Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide

Description of Study: The purpose of this study is to assess the efficacy of intranasal esketamine {28 milligram (mg), 56 mg and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide. The duration of participation will be approximately 29 weeks.

Eligibility Criteria

• Children ages 12–17 with symptoms of depression including suicidality (otherwise medically stable)

Principal Investigator: Ghada Lteif, MD

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

Funding/Study Sponsor: Janssen Research & Development, LLC

Source: https://clinicaltrials.gov/ct2/show/NCT03185819?term=esketinsui2002&rank=1

Metformin for Overweight and Obese Children and Adolescents with BDS Treated with Second Generation Antipsychotics (SGAs)

Description of Study: A prospective, large, pragmatic, randomized trial to study the impact of Metformin and healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood, anxiety) and Quality of Life.

Eligibility Criteria

• Ages eight to 19 years
• Diagnosed with any of the following bipolar spectrum disorders (BSD): bipolar I, bipolar II, unspecified bipolar and related disorders, disruptive mood dysregulation disorder (DMDD), cyclothymic disorder, other specified bipolar and related disorders as well as mood disorders not otherwise specified (if diagnosed in the past as per DSM-IV)
• Body mass index greater than 85 percent
• Receiving at least one SGA (i.e. olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, brexpiprazole or cariprazine)

Principal Investigator: Ghada Lteif, MD

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

Funding/Study Sponsor: University of Cincinnati

Source: https://clinicaltrials.gov/ct2/show/NCT02515773?term=metformin&recrs=a&cond=Bipolar+Disorder&rank=2

An Observational Longitudinal Study in Offspring of Parents with Bipolar Disorder to Evaluate the Relationship of Impairment in Psychosocial Functioning with the Manifestation of Mood Symptoms over 24 Months

Description of Study: The purpose is to follow teens and young adults who have a parent with bipolar disorder to identify those who may be at risk of developing bipolar disorder. Teens and young adults who do not have bipolar disorder themselves but who have parent diagnosed with bipolar disorder will be followed for two years.

Eligibility Criteria

• Ages 15-25
• Do NOT have bipolar disorder but have a parent with bipolar disorder
• Parent willing to confirm his or her diagnosis at the beginning of the study

Contact
Phone: 614-685-8754
Email: ChildhoodMoodDisordersLab@osumc.edu

Funding/Study Sponsor: Janssen Research & Development, LLC

Purpose of Study: This study plans to enroll up to 10 subjects who have been diagnosed with obsessive compulsive disorder (OCD). Once consented, the participants will undergo a positron emission tomography/computerized tomography (PET/CT) scan, electroencephalography (EEG) with event-related potentials (ERP), and cognitive assessments prior to the DBS surgery. After surgery, participants will repeat the PET/CT scan, EEG/ERP and cognitive assessments every six months for two years. Five study visits are required for the study. Additional visits may be required if the PET/CT scan, EEG/ERP, and cognitive assessments cannot be scheduled or completed on the same day.

Eligibility Criteria: Patients who are candidates and are scheduled for deep brain stimulation (DBS) surgery for treatment-resistant OCD under FDA approval of HDE #H050003 will be approached and asked to participate in this research study. There is no additional eligibility criterion.

Status of Study: Open to Enrollment

Principal Investigator: Ali Rezai, MD

Contact:
Phone: Amelia Hargrove, 614-366-6639
Email: amelia.hargrove@osumc.edu

Sponsor: Ali Rezai, MD

Purpose of Study: The Food and Drug Administration (FDA) gave approval of the Humanitarian Device Exemption (HDE), a humanitarian-use device for Medtronic Reclaim Therapy to Medtronic, Inc. (HDE# H050003). Medtronic Reclaim Deep Brain Stimulation (DBS) Therapy for obsessive compulsive disorder (OCD) delivers electrical stimulation to areas in the brain to help control symptoms of treatment-resistant OCD. The Medtronic Reclaim DBS Therapy is indicated for bilateral stimulation of a specific region of the brain (anterior limb of the internal capsule) in conjunction with OCD medications for treatment of chronic, severe, treatment-resistant OCD in adult patients who have failed at least three selective serotonin reuptake inhibitor medications. DBS is used as an alternative to anterior capsulotomy (different type of surgery) that is indicated for this condition.

Principal Investigator: Ali Rezai, MD

Contact:
Amelia Hargrove
Phone: 614-366-6639
Email: amelia.hargrove@osumc.edu

Addressing the Unmet Needs of Cancer Patients and Survivors

Purpose of the Study: This clinical research project offers a psychological intervention designed to prevent or reduce the sexual difficulties and stress that can follow gynecologic and breast cancer diagnosis and treatment.

Description: Over the past 20 years, our team has conducted a great deal of research with gynecologic and breast cancer patients and survivors. This research has taught us two important things. First, sexual issues are common and difficult for gynecologic and breast cancer patients. Second, until now, there have been very few resources available to these patients coping with sexual difficulties and stress following their diagnosis and treatment.

Unlike other treatments for sexual concerns or difficulties, this one is designed specifically for women treated for breast or gynecologic cancer.  Individual or group treatment will be provided to all those who participate.  All study-related treatment sessions and information are strictly confidential.

Therapy sessions take place over five months.  Study participation will also include 4 assessment interviews that will take place over the course of nine months.

There is no cost to you. The treatment associated with this study will be provided free-of-charge. In fact, all participants will be compensated for the time spent completing the study assessments.

Eligibility Criteria: If you have been diagnosed with breast or gynecologic cancer, are married or partnered, and are at least 21 years old, you may be eligible to participate.

Contact:
Nichole Storey
Phone: 614-685-8754
Email: nichole.storey@osumc.edu