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Bipolar Depression clinical trials

View clinical trials related to Bipolar Depression.

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NCT ID: NCT03484494 Not yet recruiting - Bipolar Disorder Clinical Trials

Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression

LFMSBioMGeri
Start date: March 2018
Phase: N/A
Study type: Interventional

The protocol involves functional Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy acquisitions immediately before and after Low Field Magnetic Stimulation treatment on two separate days in a sham controlled, randomized trial, in order to assess the physiologic effects of Low Field Magnetic Stimulation on brain function in a geriatric population with bipolar depression.

NCT ID: NCT03427892 Completed - Bipolar Depression Clinical Trials

Brexpiprazole for Bipolar Depression

Start date: March 1, 2017
Phase: Phase 4
Study type: Interventional

The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to assess if brexpiprazole is associated with a reduction in depressive symptom severity using the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary aims will include an assessment of the following in patients with bipolar disorder taking brexpiprazole: manic symptoms, cognition, safety and tolerability of brexpiprazole, and quality of life. Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder, development of active suicidal or homicidal ideation with plan and intent, worsening of mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe life-threatening medical condition, involuntary psychiatric hospitalization or incarceration.

NCT ID: NCT03402152 Recruiting - Bipolar Depression Clinical Trials

NRX101 Glx Biomarker Validation Study

NRX-GLX
Start date: March 15, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Subnormal level of Glutamate+Glutamine (Glx) in the Anterior Cingulate Cortex (ACC) of the brain has been associated with depression and PTSD. Similarly, interventions that increase the level of Glx in the brain, specifically electroconvulsive therapy (ECT) and intravenous ketamine infusion have been associated with a rapid decrease in depression and suicidal ideation. This effect has been demonstrated in a dose-dependent manner in randomized clinical assessments. D-cycloserine, a glycine site modulator of NMDA receptor function has been demonstrated to increase Glx in the ACC of normal volunteers. The purpose of this study is to determine whether NRX-101, an experimental drug containing a fixed dose combination of D-cycloserine and lurasidone (1) raises Glx by a greater amount than either placebo or lurasidone alone in patients with bipolar depression, and (2) whether that elevation in Glx is correlated with a decrease in depression.

NCT ID: NCT03396744 Not yet recruiting - Bipolar Depression Clinical Trials

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

LUBI
Start date: January 2018
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: NCT03396601 Not yet recruiting - Bipolar Depression Clinical Trials

NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression

SevereBD
Start date: May 1, 2018
Phase: Phase 3
Study type: Interventional

NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. NeuroRx has developed a sequential therapy consisting of IV NRX-100 (ketamine HCL) for rapid stabilization of symptoms of depression and suicidal ideation followed by oral NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for maintenance of stabilization from symptoms of depression and suicidal ideation. This study will test the hypothesis that that NRX-100 is superior to placebo in achieving rapid reduction in symptoms of depression and suicidal ideation in patients with Severe Bipolar Depression and Acute Suicidal Ideation or Behavior within 24 hours of administration.

NCT ID: NCT03396068 Not yet recruiting - Bipolar Depression Clinical Trials

NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation

SBD-ASIB
Start date: May 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. NeuroRx has developed a sequential therapy consisting of IV NRX-100 (ketamine HCL) for rapid stabilization of symptoms of depression and suicidal ideation followed by oral NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for maintenance of stabilization from symptoms of depression and suicidal ideation. The SevereBD study will test two hypotheses: 1) that NRX-100 is superior to placebo in achieving rapid reduction in symptoms of depression and suicidal ideation in patients with Severe Bipolar Depression and Acute Suicidal Ideation or Behavior, and 2) That NRX-101 is superior to lurasidone alone in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.

NCT ID: NCT03395392 Not yet recruiting - Bipolar Depression Clinical Trials

NRX101 for Moderate Bipolar Depression and Suicidal Ideation

MBD
Start date: April 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation. This study will test the hypothesis that NRX-101 is superior to lurasidone alone (the standard of care) in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.

NCT ID: NCT03349528 Not yet recruiting - Bipolar Depression Clinical Trials

Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

Start date: January 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if taking a probiotic supplement versus a placebo will reduce relapse and improve the clinical course among participants who have been hospitalized for bipolar depression.

NCT ID: NCT03339596 Recruiting - Clinical trials for Cognitive Impairment

Effects of Erythropoietin for Cognitive Side-effects of ECT

EPO-T
Start date: June 26, 2017
Phase: Phase 2
Study type: Interventional

EPO-T aims to investigate (i) whether short-term add-on treatment with erythropoietin (EPO) can reduce cognitive side-effects of ECT and (ii) whether such effects are long-lasting. Further, structural and functional magnetic resonance imaging (MRI) will be used to explore the neural underpinnings of such beneficial effects of EPO. Finally, the trial examines whether potential protective effects of EPO on cognition are accompanied by changes in markers of oxidative stress, inflammation, and neuroplasticity. It is hypothesized that EPO treatment will (i) counteract ECT-induced cognitive decline, accompanied by (ii) increased sub-regional hippocampal volume, (iii) greater memory-related hippocampal activation and reinforcement of dorsolateral prefrontal activity during memory encoding and working memory, and (iv) changes in peripheral markers of inflammation, oxidative stress and neuroplasticity. Furthermore, we hypothesize that add-on EPO-treatment will produce greater, more sustained mood improvement than ECT treatment alone.

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: N/A
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.