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Depressive Disorder, Major clinical trials

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NCT ID: NCT03761030 Terminated - Depression Clinical Trials

L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults

Start date: January 9, 2019
Phase: Phase 4
Study type: Interventional

Individuals with Late Life Depression (LLD) often have cognitive problems, particularly problems with memory, attention, and problem solving, all of which contribute to antidepressant non-response. Our group and others have shown that decreased thinking speed is the central cause of functional problems in patients with LLD. Similarly, decreased walking speed is associated with depression and carries additional risk for falls, hospitalization, and death. Available evidence suggests that declining functionality in the brain's dopamine system contributes to age-related cognitive and motor slowing. The central hypothesis of this study is that by enhancing dopamine functioning in the brain and improving cognitive and motor slowing, administration of carbidopa/levodopa (L-DOPA) will improve depressive symptoms in older adults.

NCT ID: NCT03731728 Terminated - Clinical trials for Major Depressive Disorder

Group CBT and Exercise in Management of Depression

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

INTRODUCTION: There is strong evidence indicating the effectiveness of Cognitive-Behavior Therapy (CBT) in the management of Major Depressive Disorder (MDD) and some clinical trials indicating physical exercise (PE) as an effective treatment for the disorder. However, few studies have evaluated the effect of group CBT or PE compared to wait-listing to receive treatment as usual (TAU) in the management of MDD. This study will evaluate and compare the effectiveness of: 1) group CBT plus wait-listing for TAU; versus 2) group PE plus wait-listing for TAU; versus 3) only wait-listing for TAU in management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or PE (plus wait-listed for TAU) arms of the study will achieve superior outcomes compared to participants only wait-listed for TAU. METHODS AND ANALYSIS: This is a prospective rater-blinded randomized controlled trial assessing the benefits for participants with MDD. 120 patients with MDD referred to Addiction and Mental Health (AMH) clinics in Edmonton Zone who are informed about the study and consent to participate will be randomly assigned to one of the 3 arms of the study: 1) 40 participants wait-listed for TAU will receive weekly sessions of group CBT for 14 weeks; 2) 40 participants wait-listed for TAU will receive PE 3 times a week for 14 weeks; and 3) 40 participants will only be wait-listed for TAU. Participants will be assessed at enrollment, 3 and 6 months post enrolment, mid-treatment, and at treatment completion . Their assessments will cover primary outcomes including functional variables (relationships, well-being, physical activity) and symptom variables (changes in depressive symptoms scores). Secondary client outcomes will be service variables (e.g. patient compliance, retention in treatment, patient satisfaction). In addition, participants in the intervention groups will be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point. ETHICS AND DISSEMINATION: The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong Amendment) and Good Clinical Practice (Canadian Guidelines). Written informed consent will be obtained from each subject. The study has received ethical clearance from Health Ethics Research Board of the University of Alberta (Ref. # Pro 00080975) and operational approval from the provincial health authority (AHS # 43638). The results will be disseminated at several levels, including patients, practitioners, academics/researchers, and healthcare organizations.

NCT ID: NCT03675776 Terminated - Clinical trials for Depressive Disorder, Major

Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)

Start date: October 30, 2018
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).

NCT ID: NCT03668600 Terminated - Clinical trials for Depressive Disorder, Major

Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

Start date: August 23, 2018
Phase: Phase 3
Study type: Interventional

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

NCT ID: NCT03643159 Terminated - Schizophrenia Clinical Trials

A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder

Start date: June 28, 2018
Phase: Phase 4
Study type: Interventional

The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls. In addition, secondary and exploratory objectives were to assess medication adherence, healthcare utilization and costs, and patient-reported outcomes.

NCT ID: NCT03620253 Terminated - Clinical trials for Major Depressive Disorder

Modafinil's Effects on Cognition in Remitted MDD

Start date: October 15, 2018
Phase: Phase 3
Study type: Interventional

Cognitive difficulties such as indecisiveness or inability to concentrate are core symptoms of depression with up to 90% of untreated depressed individuals experiencing these symptoms. As many as half of those who remit from a major depressive episode continue to experience residual cognitive deficits, but these symptoms are frequently overlooked in clinical practice. This leads to persistent cognitive deficits which can cause reduced level of functioning and loss of productivity. As standard antidepressants have an inadequate impact on these residual cognitive symptoms, further treatment options are required. Modafinil is a wakefulness agent with evidence that it improves some domains in cognition such as memory in those whose non-cognitive depressive symptoms have been treated over a short term period. This medication may have favourable lasting effects on cognition, such as the ability to plan and execute tasks in those who receive modafinil for a longer time period. The aim of this study is to investigate whether modafinil can enhance cognition and have additional effects on functioning and work productivity in a sample of participants who were treated for depression but who continue to experience cognitive deficits.

NCT ID: NCT03614156 Terminated - Clinical trials for Depressive Disorder, Major

Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)

Start date: August 2, 2018
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).

NCT ID: NCT03610048 Terminated - Clinical trials for Refractory Major Depressive Disorder

A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

Start date: August 9, 2018
Phase: Phase 3
Study type: Interventional

This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.

NCT ID: NCT03560518 Terminated - Clinical trials for Depressive Disorder, Major

Study of Rapastinel as Monotherapy in Patients With MDD

Start date: June 15, 2018
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).

NCT ID: NCT03537547 Terminated - Depression Clinical Trials

Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder

Start date: May 4, 2018
Phase: Phase 4
Study type: Interventional

This study aims to determine whether the GeneSight Psychotropic test can result in better treatment outcomes for patients with treatment-naive major depressive disorder