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Bipolar II Disorder clinical trials

View clinical trials related to Bipolar II Disorder.

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NCT ID: NCT05339074 Recruiting - Bipolar Disorder Clinical Trials

Maintenance Ketamine Infusions for Treatment-Resistant Bipolar Depression

KET-BD-Sustain
Start date: August 10, 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 Canadian Rapid Treatment Centre of Excellence), 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: 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: NCT05065294 Recruiting - Bipolar II Disorder Clinical Trials

Psilocybin Therapy for Depression in Bipolar II Disorder

BAP
Start date: January 28, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.

NCT ID: NCT05064319 Recruiting - Bipolar Disorder Clinical Trials

Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders

Start date: February 24, 2022
Phase: Phase 2
Study type: Interventional

This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

NCT ID: NCT04561622 Active, not recruiting - Bipolar Disorder Clinical Trials

Emotional Proactive Processing in Bipolar Disorder

PROEMO_BP
Start date: October 1, 2020
Phase:
Study type: Observational

The main objective of this project is to identify behavioral specificities of the proactive emotional brain among bipolar patients, compared to healthy subjects. These could contribute to some of the emotional processing biases that can be observed in these patients. To achieve this goal, two behavioral tasks will be administer (emotional stroop and emotional stimuli categorization task) to bipolar patients and control subjects, and their performances will be compared.

NCT ID: NCT04211428 Recruiting - Bipolar Disorder Clinical Trials

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Bipolar Disorder

Start date: March 2, 2020
Phase:
Study type: Observational

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

NCT ID: NCT04035798 Recruiting - Bipolar II Disorder Clinical Trials

add-on Low Dose Memantine in Middle-to-old Aged Bipolar II Disorder Patients

Start date: August 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators hypothesized that add-on memantine (MM) 5 mg/day may reduce chronic inflammation, and subsequently improve neuro-progression process and cognitive function in middle-to-old aged bipolar II disorder (BP-II) patients. In current proposal, the investigators will conduct a randomized double-blind placebo-controlled study. The investigators will recruit 100-120 patients with BP-II who are older than 40 years old in three years, and allocate them to add-on MM or placebo plus standard valproic acid treatment in a 1: 1 ratio. The investigators will follow up the participants for 12 weeks and measure the severity of mood symptoms, neuropsychological tests and inflammatory markers to evaluate the therapeutic effects of add-on MM.

NCT ID: NCT03822416 Completed - Schizophrenia Clinical Trials

Treating Smokers With Mental Illness

Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.

NCT ID: NCT03810703 Completed - Bipolar II Disorder Clinical Trials

Differential Responses to Drugs and Sweet Tastes

HAP
Start date: February 9, 2017
Phase: Phase 1
Study type: Interventional

Young adults who exhibit "bipolar phenotype" (BPP), defined as occasional episodes of mood elevation and heightened activity, are at risk for several psychiatric disorders, including problem use of drugs and alcohol. Mood elevation has been linked to higher alcohol consumption and alcohol use disorders. Individuals with BPP show elevated lifetime prevalence of alcohol use disorders (between 39%-61%), figures that exceed those reported in both major depression and schizophrenia. Recently, the investigators demonstrated in a controlled laboratory study that individuals with BPP (but not meeting criteria for full Bipolar I Disorder), report dampened responses to a single dose of alcohol, compared to placebo. In the current study, the investigators seek to extend these findings to determine if young adults reporting BPP, based on a questionnaire, will exhibit reduced responses to other rewarding stimuli, such as d-amphetamine and sweet tastes. The investigators hypothesize that the BPP individuals will exhibit dampened subjective responses to stimulant and sweet taste rewards compared to healthy controls.

NCT ID: NCT03641300 Active, not recruiting - Bipolar Disorder Clinical Trials

Efficacy of Convulsive Therapies for Bipolar Depression

CORRECT-BD
Start date: September 21, 2018
Phase: N/A
Study type: Interventional

This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Bipolar Disorder (BD). Research indicates that the prevalence of treatment resistance in bipolar depression is twice that of unipolar depression. The limited effectiveness of current treatments for bipolar depression coupled with the medical and economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.