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Bipolar Depression clinical trials

View clinical trials related to Bipolar Depression.

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NCT ID: NCT05357313 Recruiting - Bipolar Depression Clinical Trials

Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

Start date: June 2, 2022
Phase: N/A
Study type: Interventional

This is a randomized placebo-controlled trial to examine the efficacy of six-week bright light therapy as adjunctive treatment for patient with bipolar depression and eveningness.

NCT ID: NCT05340686 Recruiting - Bipolar Disorder Clinical Trials

Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression

Start date: October 26, 2022
Phase: N/A
Study type: Interventional

Hypothesis: the hypothesis of the study is that aerobic physical exercise (PE) performed with the method Braining accelerates recovery from bipolar depression as well as improves psychiatric and somatic health in individuals with bipolar depression Method: a randomized controlled trial with 54 patients with bipolar depression are randomized to 6 weeks of either 1) supervised aerobic PE 3 times/week, 2) supervised relaxation/stretching 3 times/week or 3) information about PE but no supervised activity.

NCT ID: NCT05339074 Recruiting - Bipolar Disorder Clinical Trials

Maintenance Ketamine Infusions for Treatment-Resistant Bipolar Depression

KET-BD-Sustain
Start date: August 11, 2022
Phase: Phase 2
Study type: Interventional

Growing evidence has supported rapid and robust antidepressant effects with subanesthetic doses of intravenous (IV) ketamine for treatment resistant depression (TRD). However, no completed or ongoing RCTs have evaluated the effects of repeated doses of IV ketamine for a homogenous sample of patients with treatment-resistant bipolar disorder depression (TRBD). The primary research goal is to determine the acute antidepressant efficacy, safety and tolerability of repeated sub-anesthetic maintenance doses of IV ketamine in, over a period of twelve weeks. Open-label ketamine infusions will be provided on a flexible schedule (every 2-4 weeks) with flexible dosing (0.5-1.0mg/kg over 40 minutes) titrated to optimize benefits, while minimizing the dosage and frequency over a 12-week extension period. All patients participating in this open-label study will have completed an acute course of infusions in a parent two-site, phase II, double-blinded midazolam-controlled RCT trial. In addition to this acute course of four infusions, a maximum of six infusions will be provided over the 12-week period. Secondary aims include evaluating effects of IV ketamine on suicidal ideations, quality of life, function and duration of effects. Herein, a two-site (University Health Network and Ontario Shores Centre for Mental Health Sciences), single-arm, open label, 12-week extension trial evaluating the effects of flexibly-dosed adjunctive ketamine infusions for TRBD to maintain antidepressant effects in participants who achieved an antidepressant response (MADRS decrease by >50%) or remission (MADRS < 12) following an acute course of four ketamine infusions is proposed. The primary outcome will be Montgomery-Åsberg Depression Rating Scale (MADRS) scores, determining by a linear mixed model from baseline to week 12. Secondary outcomes include evaluating response and remission rates, safety, tolerability (including treatment-emergent mania), and effects on suicidality, anxiety, quality of life, function and the duration of effects.

NCT ID: NCT05296356 Recruiting - Bipolar Depression Clinical Trials

OSU6162 in Bipolar Depression (OBID)

OBID
Start date: October 25, 2021
Phase: Phase 2
Study type: Interventional

An explorative, open label, single armed, flexible dose, single center, phase IIa study of 8 weeks, initiated in inpatients with bipolar depression. The study will consist of 9 visits and 1 safety visit. Inpatients with a primary diagnosis of bipolar disorder (type 1 or 2) currently in an acute depressive phase (i.e. bipolar depression) and being on stable medication with at least one mood stabilizer.

NCT ID: NCT05249309 Active, not recruiting - Clinical trials for Major Depressive Disorder

Naturalistic Study of Ketamine in the Treatment of Depression

Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

This study aims to examine the effect of ketamine in decreasing the risk of suicide in patients with depression and its effectiveness as an antidepressant agent.

NCT ID: NCT05228964 Active, not recruiting - Depression Clinical Trials

Focused Ultrasound Amygdala Neuromodulation

Start date: January 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to examine the feasibility and potential efficacy of low-intensity focused ultrasound as a method of modulating amygdala function to promote improvements in symptoms of an affective disorder. Ultrasound is frequently and safely utilized for diagnostic purposes. In this study, the investigators will utilize magnetic resonance imaging (MRI) and neuronavigation to target the left amygdala and apply ultrasound. This will be conducted once a day, 5 days a week, for 3 weeks. This will be an open-label, single-arm trial.

NCT ID: NCT05228457 Completed - Clinical trials for Treatment Resistant Depression

Intensive TMS for Bipolar Depression

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression who have failed (or not shown signs of improvement) after at least two prior treatments.

NCT ID: NCT05060549 Not yet recruiting - Bipolar Depression Clinical Trials

Dopamine D3 Receptor Occupancy in Bipolar Depression

Start date: March 31, 2024
Phase: Phase 4
Study type: Interventional

Bipolar disorder is a common condition that can cause significant disability and risk for suicide. Second generation antipsychotic medications can be used to treat depression in bipolar disorder, yet we do not know how they work. Here, we will use a recently approved medication, cariprazine (Vraylar), to treat participants with bipolar depression. They will have brain imaging with PET scans before and during treatment to understand how the medication may be working. Particularly, we will look at the role of the D3 dopamine receptor.

NCT ID: NCT05054699 Recruiting - Clinical trials for Major Depressive Disorder

Electro-Magnetic Convulsive Therapies for Depression: a Non-inferiority Study

EMCODE
Start date: May 31, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy.

NCT ID: NCT05004896 Recruiting - Bipolar Disorder Clinical Trials

Ketamine for Treatment-Resistant Bipolar Disorder

KET-BD
Start date: July 4, 2022
Phase: Phase 2
Study type: Interventional

Growing evidence has supported rapid and robust antidepressant effects with subanesthetic doses of intravenous (IV) ketamine for treatment resistant depression (TRD). However, no completed or ongoing randomized control trials (RCTs) have evaluated the effects of repeated doses of IV ketamine for a homogenous sample of patients with treatment-resistant bipolar disorder (TRBD). The primary research goal is to determine the acute antidepressant efficacy, safety and tolerability of four repeated sub-anesthetic doses of IV ketamine in moderate to severe TRBD. Secondary aims include evaluating effects of IV ketamine on suicidal ideations, quality of life, function and duration of effects. Herein, a two-site (University Health Network and Ontario Shores Centre for Mental Health Sciences), phase II, double-blinded, midazolam-controlled, two-week RCT evaluating the efficacy, safety and tolerability of four flexibly-dosed adjunctive ketamine infusions (0.5-0.75mg/kg infused over 40 minutes) for acute treatment of moderate to severe TRBD (type I & II) is proposed. The primary outcome will be Montgomery-Åsberg Depression Rating Scale (MADRS) scores, determining the between group difference in change from baseline to day 14, using analysis of covariance (ANCOVA), with 14-day MADRS as the outcome and baseline MADRS and stratification variables (sex, bipolar type) as covariates. Secondary outcomes include evaluating response and remission rates, safety, tolerability (including treatment-emergent mania), and effects on suicidality, anxiety, quality of life, function and the duration of effects (to day 28).