Adult Depression

Adult Depression

iSPOT-D: International Study to Predict Optimized Treatment - in Depression

Official Title: International Study to Predict Optimized Treatment - in Depression


Purpose of the Study: The goal of this study is to identify psychological, physical and genetic markers that may help predict response to antidepressants treatments in patients with major depressive disorder (MDD). This study will assess the impact of ‘personalized medicine’ in MDD.


Description: This is an open-label, randomized study to identify genetic markers, brain function, brain structure, and psychological and cognitive indicators that might predict response to antidepressants treatments Escitalopram, Sertraline or Venlafaxine XR. Participants must take part in 2 days of assessments and complete 8 Web-based follow up questionnaires over a 12-month period. The assessments/procedures include: baseline clinical work-up, blood collection for genetic analyses, cognitive testing and electrical brain functioning (EEG/ERP). Structural and functional data MRI data will be collected in 10 percent of participants.


Eligibility Criteria: Adults 18 – 65 years who meet the DSM IV criteria for MDD, HAM-D17 score of 16 or more


Principal Investigator: Subhdeep Virk, MD


Contact:
Phone: Erin Casey, 614-293-7109
Email: erin.casey2@osumc.edu or clinicaltrials@osumc.edu
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Funding/Study Support: BRC Operations Pty. Ltd.


Source: https://clinicaltrials.gov/ct2/show/NCT00693849?term=iSPOT-d&rank=1

Impact of GeneSight Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From a Major Depressive Disorder (MDD) and Having Had an Inadequate Response to at Least One Psychotropic Medication Included in GeneSight Psychotropic (RCT)

Official Title: Protocol ARX1006. A 12-Week, Randomized, Double-Blind, Controlled Evaluation Followed by an Open-Label, 12-Week Follow-up Period of the Impact of GeneSight Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From a Major Depressive Disorder (MDD) and Having Had – Within the Current Episode – an Inadequate Response to at Least One Psychotropic Medication Included in GeneSight Psychotropic


Purpose of the Study: To evaluate the impact of GeneSight Psychotropic, a non-invasive genetic test, and learn whether it can assist in treating clinicians’ medication selection for individuals with Major Depressive Disorder


Description: This is a 2-part study occurring over 24 weeks. Part 1 consists of 5 study visits over 12 weeks. Participants will be randomly assigned to clinicians who receive GeneSight results at the start of the 12 weeks or to clinicians who receive GeneSight results at the end of the 12 weeks. Part 2 occurs over 12 weeks, with one study visit during the last (24th) week. Both participants and clinicians will receive GeneSight results at the beginning of the 12 weeks. Participants will be evaluated on the 17-item Hamilton Depression Score and the Generalized Anxiety Disorder 7-item (GAD-7) scale.


Eligibility Criteria: Adults who have recently tried psychiatric medications for depression for at least 6 weeks and without symptom improvements or are unable to tolerate the medication and have discontinued use. Participants will receive the results of the GeneSight® test at no cost and will receive some compensation for their time.


Contact: 
Phone: Erin Casey, 614-293-7109
Email: erin.casey2@osumc.edu or clinicaltrials@osumc.edu

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Funding/Study Sponsor: AssureRx Health, Inc.


Source:
Genetic Testing Can Help You (flier)

https://clinicaltrials.gov/ct2/show/study/NCT02109939?term=ARX1006&rank=1

An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder

Official Title: Protocol CNTO136MDD2001: A Double-Blind, Placebo-Controlled, Multicenter Study of Sirukumab as Adjunctive Treatment to a Monoaminergic Antidepressant in Adults With Major Depressive Disorder.


Purpose of the Study: To evaluate the efficacy of sirukumab as adjunctive treatment to monoaminergic antidepressant therapy as compared to placebo in adults with major depressive disorder (MDD).


Description: This is a 12-week, randomized, double-blind, placebo-controlled study examining the safety and efficacy of subcutaneous injections of sirukumab as an adjunctive treatment to a monoaminergic antidepressant in adults with MDD. Participants will be evaluated on the Hamilton Depression Rating Scale (HDRS).


Eligibility Criteria: Adults 21 – 65 years diagnosed with MDD, otherwise medically stable. Exclusion: A depressive episode of more than 60 months.


Study Status: Open to enrollment


Principal Investigator: Janssen Research & Development, LLC


Contact:
Phone: Erin Casey, 614-293-7109
Email: erin.casey2@osumc.edu or clinicaltrials@osumc.edu


Funding/Study Sponsor: Janssen Research & Development, LLC


Source: https://clinicaltrials.gov/ct2/show/study/NCT02473289?term=CNTO136MDD2001&rank=1

An Efficacy, Safety and Tolerability Study of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD).

Official Title: Protocol RGH-MD-72. A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder (MDD)


Purpose of the Study: The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD.


Description: This is an 8-week, phase 3, double-blind, randomized, placebo-controlled study to assess the safety, efficacy and tolerability of cariprazine as an adjunctive treatment to antidepressant therapies in adult patients with major depressive disorder. Participants will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS), which measures symptoms of depression, and the Sheehan Disability Scale (SDS), which evaluates impairment in the domains of social, work and family life.


Eligibility Criteria: Adults ages 18 – 65 years who meet the DMS IV criteria for MDD.


Study Status: Open to enrollment


Principal Investigator: Yao Wang, MD Forest Laboratories


Contact: 
Phone: Erin Casey, 614-293-7109
Email: erin.casey2@osumc.edu or clinicaltrials@osumc.edu


Funding/Study Sponsor: Forest Laboratories, Gedeon Richter Ltd


Source: https://clinicaltrials.gov/ct2/show/study/NCT01715805?term=RGH-MD-72&rank=1

Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

Official Title: Protocol RGH-MD-76. A Phase 3, Long-Term, Open-Label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder


Purpose of the Study: To evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD)


Description: This is a 26-week, phase 3 study to examine the long-term safety and tolerance of cariprazine as an adjunctive treatment for MDD patients with inadequate response to ADT. Participants will be evaluated on adverse events, clinical laboratory parameters, vital signs, electrocardiograms, EPS scales and ophthalmologic examination.


Eligibility Criteria: Adults 18- 65 years who meet the DMS IV criteria for MDD and have inadequate response to common or current ADT


Study Status: Ongoing, not recruiting


Contact:
Phone: Nicole Storey, 614-293-7109
Email: clinicaltrials@osumc.edu


Funding/Study Sponsor: Forest Laboratories, Gedeon Richter Ltd.


Source: https://clinicaltrials.gov/ct2/show/study/NCT01838876?term=RGH-MD-76&rank=1

Adolescent Depression

Adolescent Depression

Protocol 44-02219-000: A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

Purpose of the Study: The purpose of this study is to evaluate the safety and efficacy of TMS as a monotherapy antidepressant in depressed adolescents who have not responded sufficiently to at least one antidepressant medication.


Description: This is a randomized, sham-controlled trial evaluating TMS therapy in depressed adolescents.


Eligibility Criteria: Adolescents ages 12-21 with a diagnosis of depression, who have not responded sufficiently to antidepressant medication.


Study Status: Open to enrollment


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


Funding/Study Sponsor: Neuronetics, Inc.

Protocol VLZ-MD-22. A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder

Purpose of the Study: The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone compared with placebo or fluoxetine in pediatric outpatients (7-17 years of age) with major depressive disorder (MDD).


Description: This is an 8-week, randomized, double-blind, placebo- and active- control study evaluating the safety, efficacy and tolerability of vilazodone compared to fluoxetine or placebo in children and adolescents with MDD. Participants will be evaluated on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score and Clinical Global Impressions-Severity (CGI-S) Score.


Eligibility Criteria: Otherwise healthy male and female outpatients 7 – 17 years with MDD. Exclusions: Seizure disorder


Study Status: Open to enrollment


Contact:
Phone: Erin Casey, 614-293-7109
Email: erin.casey2@osumc.edu or clinicaltrials@osumc.edu


Funding/Study Sponsor: Forest Laboratories


Source: https://clinicaltrials.gov/ct2/show/study/NCT02372799?term=VLZ-MD-22&rank=1

Protocol VLZ-MD-23: An Open-label, Long-term, Safety Study of Vilazodone in Pediatric Patients With Major Depressive Disorder

Purpose of the Study: The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone for the treatment of major depressive disorder (MDD) in pediatric outpatients (7-17 years).


Description: This is a 26-week, phase 3, single group study evaluating the long-term safety and tolerability of vilazodone in children and adolescents with MDD. Participants will be evaluated for the number of Treatment Emergent Adverse Events.


Eligibility Criteria: Having participated in VLZ-MD-22 study.


Study Status: Open to enrollment


Contact:
Phone: Erin Casey, 614-293-7109
Email: erin.casey2@osumc.edu or clinicaltrials@osumc.edu


Funding/Study Sponsor: Forest Laboratories


Source: https://clinicaltrials.gov/ct2/show/study/NCT02436239?term=VLZ-MD-23&rank=1

Obsessive Compulsive Disorder

Obsessive Compulsive Disorder

Deep Brain Stimulation (DBS) Therapy for Obsessive Compulsive Disorder (OCD)

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

Reclaim Deep Brain Stimulation (DBS) Therapy for Obsessive Compulsive Disorder

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

Women's Behavioral Health

Women's Behavioral Health

Enhancing Sexuality After Cancer

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

Other Conditions

Other Conditions

Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder (Current or Most Recent Episode Manic)

Official Title: Protocol A1281198: A Phase 3, Multicenter, 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder (current or most recent episode manic)


Purpose of the Study: The purpose of this study is 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).


Description: This is a 4-week, randomized, double-blind, placebo-controlled study examining the safety and efficacy of flexible oral doses of ziprasidone in children and adolescents with bipolar I disorder. Participants will be evaluated on the Young Mania Rating Scale (YMRS), the Clinical Global Impression of Severity (CGI-S), and the Clinical Global Impression – Improvement (CGI-I).


Eligibility Criteria: Males and females 10 – 17 years meeting the DSM V criteria for bipolar I disorder (manic or mixed). Exclusion: imminent risk of suicide or homicide as judged by investigator, other serious or unstable medical illness


Study Status: Open to enrollment


Contact:
Phone: Erin Casey, 614-293-7109
Email: erin.casey2@osumc.edu or clinicaltrials@osumc.edu


Funding/Study Sponsor: Pfizer


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

Evaluating the Efficacy, Safety and Tolerability of Cariprazine in Patients with Bipolar I Depression

Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in Patients with Bipolar I Depression.


Purpose of the Study: To assess the efficacy of cariprazine for treatment of bipolar depression.


Eligibility Criteria: 18-65 years old with diagnois of bipolar I disorder, currently depressed.


Study Status: Open to enrollment


Contact:
Phone: Erin Casey, 614-293-7109
Email: erin.casey2@osumc.edu or clinicaltrials@osumc.edu

Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects with Severe Post-partum Depression

Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects with Severe Post-partum Depression.


Purpose of the Study: To determine the efficacy of an investigational drug on Post-Partum depression


Eligibility Criteria: Females 18-45 with post-partum depression, resistant to antidepressant, less than 6 months post-partum


Study Status: Open to enrollment


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

Study of Schizophrenia or Schizophreniform Disorder to Compare Disease Progression and Disease Modification Following Treatment with Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics

Official Title: A Prospective, Matched-Control, Randomized, Open-Label, Flexible-Dose, Study in Subjects with Recent-Onset Schizophrenia or Schizophreniform Disorder to Compare Disease Progression and Disease Modification Following Treatment with Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics.


Purpose of the Study: To compare disease progression and disease modification following treatment with Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics.


Eligibility Criteria: 18-35 years old. First diagnosis of psychosis within the past 2 years.


Study Status: Open to enrollment


Contact:
Phone: Erin Casey, 614-293-7109
Email: erin.casey2@osumc.edu or clinicaltrials@osumc.edu

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