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Bipolar Depression clinical trials

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NCT ID: NCT04569448 Recruiting - Bipolar Depression Clinical Trials

Brexpiprazole Treatment for Bipolar I Depression

Start date: May 10, 2021
Phase: Phase 3
Study type: Interventional

Bipolar disorder (BD) is a frequent and lifelong recurrent mood disorder with treatment-resistant depressive episodes. Importantly, depressive symptoms and cognitive decline are major determinants of functionality and quality of life in this clinical population. There is robust evidence that individuals with BD have neurocognitive deficits (especially in memory and executive functioning domains) compared to the healthy population. These deficits are present in all mood states and can greatly affect patients' functional capacity, often more so than mood symptoms themselves. Many pharmacological treatments for BD adversely affect cognition, and those that are beneficial can be difficult to use. There is thus a pressing need to identify a safe, easy-to-use medication that can target both cognitive deficits and depressive symptoms in BD. It is expected that Brexpiprazole adjunctive treatment will be efficacious in treating BD type I and type II depression by improving mood symptoms, as well as cognitive capacity and global functioning, and that such changes will be accompanied by concurrent alterations in associated brain structures.

NCT ID: NCT04480918 Recruiting - Clinical trials for Major Depressive Disorder

University of Iowa Interventional Psychiatry Service Patient Registry

Start date: November 2, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to examine the effects of interventional/procedural therapies for treatment-resistant depression (TRD) and Obsessive-Compulsive Disorder (OCD). These treatments include electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), racemic ketamine infusion and intranasal esketamine insufflation. The investigators will obtain various indicators, or biomarkers, of a depressed individuals' state before, during, and/or after these treatments. Such biomarkers include neurobehavioral testing, neuroimaging, electroencephalography, cognitive testing, vocal recordings, epi/genetic testing, and autonomic nervous system measures (i.e. "fight-or-flight" response). The results obtained from this study may provide novel antidepressant treatment response biomarkers, with the future goal of targeting a given treatment to an individual patient ("personalized medicine").

NCT ID: NCT04235686 Recruiting - Bipolar Depression Clinical Trials

8 Week Multi-site Study of MYDAYIS® for Bipolar Depression

Start date: July 17, 2020
Phase: Phase 2
Study type: Interventional

This protocol is a Phase 2 multi-site study which aims to evaluate the safety and effectiveness of MYDAYIS® as adjunctive therapy for adults with bipolar depression. Results from this study WILL NOT be used to contribute to an approval of MYDAYIS ® for this indication.

NCT ID: NCT04059952 Recruiting - Bipolar Depression Clinical Trials

Mechanism of Action of Electroconvulsive Therapy

MoA-ECT
Start date: June 28, 2019
Phase:
Study type: Observational

This is an observational neuroimaging study assessing the effects of ECT on the brains of patients with unipolar and bipolar depression.

NCT ID: NCT03748446 Recruiting - Clinical trials for Major Depressive Disorder

Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder

Start date: December 5, 2019
Phase: Early Phase 1
Study type: Interventional

The investigators will test the hypothesis that inhaled xenon will produce a rapid improvement in depressive symptoms in patients suffering from treatment-resistant depression. Specifically, the investigators will conduct a parallel randomized, double-blind crossover study that will compare the effects of xenon-oxygen (35:65 ratio by volume) added to treatment as usual (X-TAU group) to the effects of nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group). A total of 20 severely depressed patients, 10 with major depressive disorder (MDD) and 10 with Bipolar Depression (BP), will be exposed in random order to N-TAU and X-TAU in a double-blind protocol.

NCT ID: NCT03711019 Recruiting - Depression Clinical Trials

Efficacy of Convulsive Therapies During Continuation

CORRECT-C
Start date: October 22, 2018
Phase: N/A
Study type: Interventional

This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) and two different forms of electroconvulsive therapy (ECT) in sustaining response during and after a course of continuation treatment.

NCT ID: NCT03603561 Recruiting - Depression Clinical Trials

Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases. Phase 1: Bipolar depressed patients will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews (M.I.N.I.-Plus 5.0.0, HRSD-17). The presence of exclusion criteria will be evaluated. Eligible patients will undergo MRI brain imaging for TMS neuronavigation Phase 2: Baseline clinical, cognitive and psychomotor assessments will take place. Patients will also undergo blood samples for laboratory and research assessments. TBS involves applying triple-pulse 50 Hz bursts given at a rate of 5 Hz uninterrupted trains (1). Patients will be treated with in total 20 continuous Theta Burst Stimulation (cTBS) session (900 pulses per session) over the right dorsolateral prefrontal cortex, which will be spread over 4 days. A stimulation intensity of 100% of the subject's resting motor threshold (rMT) of the right abductor pollicis brevis muscle will used. Patients will be randomized to receive either the real cTBS or sham treatment. Sham stimulation will be applied with a sham coil. The sham coil produces identical sounds but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. The investigators expect that real cTBS treatment and not sham will result in a significant and clinical meaningful response. Phase 3: Two post-treatment assessment moments will take place respectively 3 (max. 4) days and 10 (max. 11) days after the last treatment day. The assessments are the same clinical, cognitive and psychomotor assessments as in phase 2.

NCT ID: NCT03396744 Recruiting - Bipolar Depression Clinical Trials

Bright Light Therapy in the Treatment of Non-seasonal Bipolar Depression

LUBI
Start date: September 30, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Bipolar disorder (BD) is a severe brain disorder characterized by the recurrence of mood episodes. Depressive episodes in BD are frequently refractory and clinicians have few treatment options. Bright light therapy (BLT, also named phototherapy) is a promising emerging antidepressant strategy that is lacking evidence-based guidelines for its prescription in BD, including to avoid side effects such as manic switches. In this context, this study aimed to evaluate modalities of the BLT dosage (time of exposure) escalation depending on the tolerance (manic symptoms) in two groups exposed either during the morning or at mid-day.

NCT ID: NCT03336918 Recruiting - Depression Clinical Trials

Lithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder

Start date: December 7, 2017
Phase:
Study type: Observational

Lithium is highly effective in the treatment of bipolar disorder. This study aims to investigate, for the first time, the impact of lithium monotherapy on the structural and functional connectivity of the brain using MRI imaging.

NCT ID: NCT02549547 Recruiting - Clinical trials for Major Depressive Disorder

Jump Step - A Participatory Approach to Physical Activity & Mental Wellness

JumpStep
Start date: August 2015
Phase: N/A
Study type: Interventional

The WHO, the Pan American Health Organization, the EU Council of Ministers, the World Federation of Mental Health, and the UK Royal College of Psychiatrists all agree -"there can be no health without mental health". Within Canada, 6.7M people live with a mental illness and when family and caregivers are included almost everyone is affected. A systematic review (2014) concluded that physical activity has a significant potential for reducing depressive symptoms in people with a mental illness. Globally, physical inactivity is "pandemic". Current guidelines recommend a minimum of only a 150 minutes a week of moderately vigorous exercise but 85% of Canadians do not meet the national recommendations. How then can people with depression be motivated to become physically more active? Group Medical Visits (GMVs) can be used to provide health services and they have proven effective in some settings, including mood disorders. As well as providing economic and resource efficiencies, the GMV model has the potential to add a 'support group/accountability' element for behavioural interventions such as physical activity promotion; such influence is not present in an individual patient-physician consultation. "Jump Step" is a 14-week program within a GMV setting designed to motivate and support people with depression to engage in regular physical activity. The investigators seek to design, implement, and evaluate the effectiveness of the Group Medical Visits focused on promoting physical activity for patients with depression.