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Depressive Disorder, Major clinical trials

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NCT ID: NCT02120729 Active, not recruiting - Clinical trials for Major Depressive Disorder

Pharmacogenetic Decision Support IT System for Psychiatric Hospitalization: RCT

CYP-GUIDES
Start date: March 2014
Phase: N/A
Study type: Interventional

This Randomized Clinical Trial (RCT) compares outcomes in patients with major depressive disorder (MDD) treated according to the patient's CYP2D6 genotype status versus empiric "standard-of-care" psychotropic therapy. The hypothesis is that provision of medication based on the functional status of the patient's CYP2D6 enzyme inferred from genotype results within 48 hours of admission to treating clinicians will, through refined selection of psychotropic medication during hospitalization, decrease length of psychiatric hospitalization stay and decrease the rate of 30 day re-admission. The trial setting is the Hartford Hospital Institute of Living (IOL). The IOL operated the Clinical Evaluation and Monitoring System (CEMS), an innovative electronic messaging system developed by Co-Investigator Dr. J.W. Goethe. The Hartford Hospital Genetics Research Center (GRC) performs the genotype testing. CYP2D6 genotype analysis detects all known polymorphisms that result in an enzyme with sub-normal or supra-normal function. In this study, CEMS transmits clinically actionable guidance based on the patient's genotype to the clinician, advancing the medication alerts in real time. The RCT will test the effects of timely incorporation of medication recommendations based on CYP2D6 genotype into CEMS. The RCT randomizes patients to standard therapy (Group S) for whom CYP2D6 genetic information is determined but not transmitted to the treating clinician, allowing psychotropic therapy to be empirically determined, and to genetically guided therapy (Group G) where genotyping result and treatment recommendations are furnished via CEMS to the clinician within 48 hours of admission. For patients in Group G who are poor or rapid metabolizers, medications primarily metabolized by the CYP2D6 enzyme are proscribed. The primary outcome is hospital length of stay and the secondary outcome, the frequency of 30 day hospital readmission. Additional genetic stratification of both Group S and Group G will allow investigation of specific psychotropic usage. The expected benefits are (1) quantitative understanding of the effect of providing CYP2D6 pharmacogenetic information on length of hospitalization, 30 day readmission rate, and associated costs; and (2) objective benchmarking for the comparative effectiveness of CYP2D6 genotyping for guiding psychotropic therapy.

NCT ID: NCT02046330 Active, not recruiting - Clinical trials for Major Depressive Disorder

Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression

Start date: November 2013
Phase: N/A
Study type: Interventional

We propose a clinical study of medial forebrain bundle DBS as a treatment in 20 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Perceptâ„¢ PC system manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 70 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB.

NCT ID: NCT01798407 Active, not recruiting - Clinical trials for Treatment Resistant Major Depressive Disorder

DBS of the Lateral Habenula in Treatment-Resistant Depression

Start date: February 2013
Phase: N/A
Study type: Interventional

This research study will investigate the safety, tolerability, and benefit of bilateral deep brain stimulation (DBS) to the lateral habenula in subjects with treatment-resistant major depression (TRD) secondary to either nonpsychotic unipolar major depressive disorder (MDD), or bipolar disorder (BD) I. Six adult subjects with TRD will be treated in this single-site study at Baylor College of Medicine; subjects will be chronically symptomatic with significant functional disability, and will have demonstrated resistance to standard somatic and pharmacotherapeutic treatments. The primary outcome measure will be the change in the 17-item Hamilton Depression Rating Scale (HDRS^17) six months after the commencement of stimulation.

NCT ID: NCT01787240 Active, not recruiting - Clinical trials for Major Depressive Disorder

Neurobiological Bases of Placebo Response in Major Depressive Disorder

Start date: September 2014
Phase: Phase 4
Study type: Interventional

We are doing this research study to find out if people who get better while taking a specific kind of antidepressant medication (a selective serotonin reuptake inhibitor, or SSRI) and people who get better while taking placebo (an inactive substance) have similar chemicals in their brains. Some participants may complete a procedure called Acute Tryptophan Depletion (ATD), which is a way to study the role of serotonin in depression. Some participants may also undergo a magnetic resonance-positron emission tomography (MR-PET) scan.

NCT ID: NCT01749124 Active, not recruiting - Schizophrenia Clinical Trials

My Coach Connect: An Automated Telephone-based Reporting System for Patients With Mental Illness

MCC
Start date: December 2012
Phase: N/A
Study type: Interventional

This is a pilot study for a novel, automated telephone system called "My Coach Connect". The purpose of the study is to evaluate the feasibility and effectiveness of this telephone tool while engaging clients and providers in discussion groups and surveys to better understand how this tool impacts the care provided and their overall experience in healthcare.

NCT ID: NCT01743716 Active, not recruiting - Clinical trials for Major Depressive Disorder

Genetic and Neural Predictors of Adolescent Depression

Start date: April 2013
Phase:
Study type: Observational

This study aims to examine the relationship between mood and brain activity in adolescent girls in order to better understand the genetic and neural predictors of adolescent depression. The participants in this study will be healthy female adolescents aged 12-14 and their mothers. They will participate for a total of six months. Adolescent participants will have three study sessions at McLean Hospital, and during two of them, their mothers will also have assessments. Adolescent assessments will include interviews, questionnaires, computer tasks, and collection of a saliva sample for genetic analyses. Their second study visit will include an fMRI scan. Parent assessments will include an interview, questionnaires, and a computer task.

NCT ID: NCT01567943 Active, not recruiting - Schizophrenia Clinical Trials

Contingency Management of Alcohol Abuse in the Severely Mentally ILL

CM ETG
Start date: March 2012
Phase: N/A
Study type: Interventional

The investigators will evaluate the efficacy of a comprehensive 12-week contingency management intervention for treating alcohol dependence for persons with severe mental illness who are seen within the context of a community mental health center setting. The primary contingency will be submission of alcohol-free urines. Additional reinforcers will be provided for intensive outpatient addiction treatment attendance. Reinforcers will be vouchers or actual items useful for day-to-day living. Participants will be 120 adults diagnosed with alcohol dependance and severe mental illness.

NCT ID: NCT01557946 Active, not recruiting - Clinical trials for Major Depressive Disorder

Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression

Start date: March 2012
Phase: Phase 2
Study type: Interventional

Primarily, this study seeks to evaluate whether citalopram treatment is associated with an increase in the Glutamine (Gln)/Glutamate (Glu) ratio in the anterior cingulate cortex (ACC) from baseline to day 3 of treatment. Additionally, this study would like to examine whether citalopram treatment is associated with an increase in the Gln/Glu ratio in the ACC from baseline to day 7 of treatment.

NCT ID: NCT01556971 Active, not recruiting - Major Depression Clinical Trials

Efficacy Study of Botox for Depression

Start date: February 2011
Phase: Phase 4
Study type: Interventional

The objective of this proposed study is to obtain data on the efficacy of Botox in reducing symptoms of MDD in male and female patients between the ages of 18 and 65 years old. The secondary object is to visually assess each patient's frown before and after the Botox injection to determine if there is a correlation between changes in the frown and changes in mood. The patients will be photographed at screening, visit 2 and 3. Their frown lines will be compared to determine if there is a visible improvement in the frown lines corresponding to an improvement in the efficacy rating scores.

NCT ID: NCT01488266 Active, not recruiting - Clinical trials for Major Depressive Disorder

Aripiprazole Augmentation Versus Switching to Different Class of Antidepressants in Major Depressive Disorder

Start date: November 2011
Phase: N/A
Study type: Interventional

The objective of this study is to compare the efficacy and safety of aripiprazole as adjunctive therapy versus switching to different class of antidepressants for treating major depressive disorder partially or minimally responsive to ongoing antidepressant treatment.