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Depression clinical trials

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NCT ID: NCT02845349 Withdrawn - Major Depression Clinical Trials

Vortioxetine for the Treatment of Major Depression and Co-morbidities After Traumatic Brain Injury (TBI)

Start date: October 2016
Phase: Phase 3
Study type: Interventional

Traumatic brain injury (TBI) is a major public health problem with an annual incidence of about 1.7 million per year. TBI is associated with various long-term morbidities. Among them, psychiatric disturbances are the major cause of chronic disability and poor quality of life. Major depression is the common psychiatric sequela post TBI with rates ranging from 13% at 1 year to 60% at 8 years after TBI. Major depression after TBI (henceforth referred to as TBI depression) is often associated with comorbid neuropsychiatric symptoms (NPS) such as anxiety, aggression, substance abuse and cognitive deficits that often makes treatment difficult. Despite increased rates of depression, there is no Food and Drug Administration (FDA) approved drug/s for its treatment. The investigators propose to address these limitations by use of a novel serotonergic agent, vortioxetine, which has a multimodal mechanism of action through serotonin transporter (SERT) inhibition, 5-hydroxytryptamine (5-HT)3, 7, and 1D receptor antagonism, 1B receptor partial agonism, and 1A receptor agonism. Overarching Goal: The overarching goal of the proposed pilot study is to determine the effectiveness and safety of vortioxetine for the treatment of post-TBI depression and co-morbid NPS. Study Design: The study design will include a DBPCT of 30 TBI patients of all severities who meet the DSM 5 criteria for major depression. A total of 150 will be consented to allow for screen failures. Written informed consent will be obtained from these patients. Subjects will be followed for a total of 12 weeks. Subjects will be randomized to either the vortioxetine arm (N=15) or placebo arm (N=15). The treatment group will receive vortioxetine 10mg per day, which will be increased to 20 mg or decreased to 5 mg, if deemed clinically necessary, at week 4 or 8. Subjects will have a total of 4-5 visits: Baseline evaluation (1 or 2 visits) and follow-up visits at weeks 4, 8 and 12. Well-validated psychiatric instruments will be used to compare the effectiveness of vortioxetine versus placebo treatment at week 12 compared to baseline Relevance: This study has the potential to provide strong preliminary evidence for the use of vortioxetine as a safe and novel agent for treatment of TBI depression and its psychiatric co-morbidities. If found to be effective, results from this study can be used to design larger studies and also determine brain changes associated with its use via neuroimaging.

NCT ID: NCT02637466 Withdrawn - Clinical trials for Unipolar Major Depression

Vortioxetine for MDD, Cognition, and Systemic Inflammatory Biomarkers

Start date: July 2016
Phase: Phase 4
Study type: Interventional

The purpose of this antidepressant study is to determine the efficacy of vortioxetine on depression and cognition in 80 women with breast cancer, and to elucidate inflammatory-mediated mechanisms by which depression and its treatment influence cancer outcome. Our hypothesis is that effective vortioxetine antidepressant therapy in depressed women with breast cancer will attenuate increased intermediate endpoints of inflammation that contribute to the pathogenesis of depression, cognitive impairment, and cancer progression

NCT ID: NCT02544126 Withdrawn - Depression Clinical Trials

Computer-Based Intervention in HIV-Positive Young Adults

Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate how working with a computer program may affect mood, feelings, overall health, and markers in blood in young adults with HIV.

NCT ID: NCT02454426 Withdrawn - Clinical trials for Coronary Artery Disease

Vortioxetine in Patients With Major Depressive Disorder and Coronary Artery Disease

Start date: April 2016
Phase: Phase 0
Study type: Interventional

This is a preliminary, open-label, clinical trial designed to assess the efficacy, safety, and tolerability of vortioxetine for the treatment of major depressive disorder in patients with coronary artery disease. In addition, the study will assess the effects of vortioxetine on heart rate variability in these patients.

NCT ID: NCT02410421 Withdrawn - Depressive Disorder Clinical Trials

e-PAT Neuromod Evaluation of Personalized rTMS for Resistant Depression

Start date: n/a
Phase: Phase 2
Study type: Interventional

Although repetitive trans-cranial magnetic stimulation (rTMS) is an effective therapy for resistant depression, it still fail to remit up to 70% of these patients. We hypothesize that personalizing the procedure using functional MRI to better select dysfunctional regions and robotic coil placement to stimulate these regions homogeneously, will increase its efficacy. Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial direct current stimulation (tDCS). In this small proof of principle study our primary outcome measure will be the correction of the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary outcome measurements.

NCT ID: NCT02295787 Withdrawn - Depression Clinical Trials

Intranasal Ketamine for Late-Life Depression and Suicidal Ideation

Start date: July 2015
Phase: Phase 4
Study type: Interventional

The investigators of this study plan to investigate the feasibility and efficacy of repeated doses of intranasal ketamine in severely depressed patients who are at least 65 years of age and experiencing suicidal ideation. The results of the study could lead to development of new strategies for treating depression.

NCT ID: NCT02238730 Withdrawn - Depression Clinical Trials

Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy

Start date: September 2014
Phase: N/A
Study type: Interventional

To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.

NCT ID: NCT02232438 Withdrawn - Depression Clinical Trials

Psychotherapy for Depressed or Anxious Adolescents With Cancer

Start date: January 2015
Phase: N/A
Study type: Interventional

At present, there are no established treatments for depression or anxiety in adolescents with cancer, creating an important clinical and research gap. Fortunately, there is now substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed and anxious adolescents in the general population.

NCT ID: NCT02212613 Withdrawn - Clinical trials for Major Depressive Disorder and Irritability

Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability

Start date: September 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to explore the effects of fixed-dosed brexpiprazole adjunctive treatment in subjects with Major Depressive Disorder with irritability

NCT ID: NCT02072252 Withdrawn - Depressive Symptoms Clinical Trials

Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men

Start date: August 14, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether a mobile phone application ("app") for symptoms of depression and anxiety is practical and acceptable to young men who are attracted to men, and whether it reduces their anxiety and depressive symptoms. The investigators will also evaluate whether reductions in symptoms are maintained over a 10 week follow-up period after young men complete the mobile phone intervention.